DIALYSIS & VASCULAR ACCESS PRODUCTS www.medcomp.net
www.medcomp.net
About Medcomp edcomp® develops, manufactures, markets and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the vascular access field. Our company’s engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve. Currently one of the world’s largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies. Message to the Customers In everything we do, from research and development to manufacturing, packaging, delivery and support, our first consideration is the patient. It is vitally important to us that, regardless of age, socio-economic status or type of healthcare treatment required, that every patient receives the best that Medcomp can provide. We dedicate ourselves to supplying the highest quality, innovation and customer service with every device we sell. Our History Medcomp was founded in 1978 to manufacture and market vascular access catheters for acute hemodialysis. At that time catheter designs were simple, consisting of a single lumen catheter for single-needle dialysis or double lumen catheters for continuous-flow dialysis. As the need for new products grew with the advent of increasingly complex procedures, Medcomp emerged as a premier developer of innovative devices using our in-house staff of engineers working All Medcomp products are developed in accordance with all FDA Quality Systems Regulations, European Medical Device Directives (CE), Japanese GMPI and numerous other international regulations and standards to ensure safety and performance. Medcomp is ISO 13485:2016 and MDSAP certified by BSI Assurance UK Limited, maintains certification to Annex II as defined in Medical Device Directive 93/42 EEC, and is certified by BSI Group The Netherlands N.V. We are audited regularly. in conjunction with some of the preeminent physicians in the field of nephrology and vascular access. Building on our pioneering Tesio®, Split Cath® and Duo-Flow® products, Medcomp continues to dominate the market in both new and proven dialysis, interventional and accessory devices. Today our contributions to the medical devices field total more than 75 product lines and thousands of distinct products. In order to better support our professional clients, we began a successful transition in 2006 from a distributor-based sales system to a dedicated sales force populated by highly skilled, clinically trained sales professionals. Medcomp is and will continue to be a stable, financially sound, privately held company wholly dedicated to the satisfaction of patients, its customers and its employees at every level. Development & Production Medcomp’s reputation and growth can be attributed to our diversely disciplined group of engineers specializing in biomedical and mechanical engineering, collaboration with esteemed professionals, and readiness to listen to suggestions and comments from members of the medical community. By continually improving on existing technology, Medcomp is able to provide a catheter to suit every medical requirement while also considering the patient’s comfort. Patients, physicians and nurses can rely on a Medcomp device to do its job and help make any treatment a more successful one. DIALYSIS & VASCULAR ACCESS PRODUCTS m
TABLE OF CONTENTS PEDIATRIC Pediatric Dignity® CT...........3 Pediatric Split Cath® ............ 3 Vascu-PICC® TLS . . . . . . . . . . . . . 4 MST . . . . . . . . . . . . . . . . . . . . . . . 5 LONG TERM Pediatric Split Cath® ............ 9 Split Cath® III . . . . . . . . . . . . . . . . . 9 Tesio® ..................... 11 Titan HD . . . . . . . . . . . . . . . . . . . 12 Hemo-Flow® ................ 13 Hemo-Flow® XF . . . . . . . . . . . . . 13 Hemo-Cath® LT . . . . . . . . . . . . . . 14 Symetrex® .................. 15 SHORT TERM SLX . . . . . . . . . . . . . . . . . . . . . . . 19 Duo-Split® .................. 20 Hemo-Cath® ST . . . . . . . . . . . . . 22 Duo-Flow® 400XL . . . . . . . . . . . . 23 Duo-Flow® .................. 24 Duo-Flow® Side X Side . . . . . . . . 25 Duo-Flow® Soft-Line® .........26 T-3® CT . . . . . . . . . . . . . . . . . . . . 27 Tri-Flow . . . . . . . . . . . . . . . . . . . . 27 Trio-CT® ................... 28 PERITONEAL I-Series . . . . . . . . . . . . . . . . . . . . 31 V-Series . . . . . . . . . . . . . . . . . . . 32 X-Series . . . . . . . . . . . . . . . . . . . 33 PD Accessories . . . . . . . . . . . . . 33 DRAINAGE Breeze® Centesis . . . . . . . . . . . . 37 Breeze® All Purpose Drain . . . . . 38 Breeze® XS All Purpose Drain . . 39 Breeze® Biliary Drain . . . . . . . . . 40 Drain Accessories . . . . . . . . . . . 41 PORTS Dignity® CT . . . . . . . . . . . . . . . . . 45 Dignity® Titanium . . . . . . . . . . . . . 47 Pro-Fuse® CT . . . . . . . . . . . . . . . 48 PICCS Pro-PICC® ................. 51 Vascu-PICC® ................ 52 Vascu-PICC® TL 53 Vascu-PICC® TLS . . . . . . . . . . . . 54 Valved Pro-PICC® ........... 55 MIDLINES Midline . . . . . . . . . . . . . . . . . . . . 59 CT Midline . . . . . . . . . . . . . . . . . . 60 CVCs Pro-Line® ................... 63 CVC Catheter . . . . . . . . . . . . . . . 65 Tri-Flow . . . . . . . . . . . . . . . . . . . 66 ACCESSORIES Micro-Stick® ................ 69 Peelable Introducers . . . . . . . . . 71 Guidewires . . . . . . . . . . . . . . . . . 72 Dilators . . . . . . . . . . . . . . . . . . . . 72 Tunnelers . . . . . . . . . . . . . . . . . . 73 Introducer Needles . . . . . . . . . . . 73 C-Arm Drapes . . . . . . . . . . . . . . 73 Probe Cover Kits . . . . . . . . . . . . 74 Vein Pick . . . . . . . . . . . . . . . . . . 74 Repair Kits . . . . . . . . . . . . . . . . . 74 ORDERING INFO & POLICIES P: 215-256-4201 • F:215-256-1787 • www.medcomp.net
PEDIATRIC Pediatric Dignity® Pediatric Split Cath® Vascu-PICC® TLS MST IMPORTANT RISK INFORMATION PEDIATRIC DIGNITY® Indications for Use: The CT Power Injectable Implantable Infusion Ports are indicated for pediatric patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. The maximum recommended infusion rate is 5ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle. Contraindications: This device is contraindicated for catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinch-off. The device is also contraindicated: When the presence of device related infection, bacteremia, or septicemia is known or suspected. When the patient’s body size is insufficient for the size of the implanted device. When the patient is known or is suspected to be allergic to materials contained in the device. If severe chronic obstructive lung disease exists. If the prospective insertion site has been previously irradiated. If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures. If local tissue factors will prevent proper device stabilization and/or access. PEDIATRIC SPLIT CATH® Indications for Use: The Medcomp® Pediatric Split Cath® is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis and in pediatric, adolescent, and adult patients as determined by the prescribing physician. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the Subclavian and femoral vein. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. VASCU-PICC® TLS Indications for Use: The 1.9F Vascu-PICC® is a long-term catheter intended for central venous access via peripheral insertion in neonates, infants and children. It may be used for administration of fluids, medication and nutritional therapy. Indications for Use: The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants and children. It may be used for the administration of fluids, medication and nutritional therapy. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. The presence of skin related problems around the insertion site (infection, phlebitis, scars, etc.) The presence of device related bacteremia or septicemia. Previous history of venous/subclavian thrombosis or vascular surgical procedures at insertion site. Fever of unknown origin. The patient’s body size is insufficient to accommodate the size of the implanted device. The patient is known or is suspected to be allergic to materials contained in the device. Past irradiation of prospective insertion site. Local tissue factors will prevent proper device stabilization and/or access. PEDIATRIC MST Indications for Use: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children. Contraindications: • This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. • The presence of skin related problems around the insertion site (infection, phlebitis, scars, etc.) • The presence of device related bacteremia or septicemia. • Previous history of venous/ subclavian thrombosis or vascular surgical procedures at insertion site. • Fever of unknown origin. • The patient’s body size is insufficient to accommodate the size of the implanted device. • The patient is known or is suspected to be allergic to materials contained in the device. • Past irradiation of prospective insertion site. Local tissue factors will prevent proper device stabilization and/or access. Refer to Instructions for Use provided with the product for complete instructions, warnings, precautions, and contraindications. Observe all instructions for use prior to using products. Failure to do so may result in patient complications. 2 Pediatric
Catheter Material Polyurethane Catheter Size 5F Port Material Plastic Catheter Configurations Attachable, Pre-Attached Power Injection Rating 5cc/sec @ 300psi Mini Profile Chest or Arm Placement Patient-Centric Design Mini Configuration PEDIATRIC SET MRCTI50041MP 5F DIGNITY® MINI PROFILE CT PORT ATTACHABLE 5/BOX MRCTI50841MP 5F DIGNITY® MINI PROFILE CT PORT PRE-ATTACHED 5/BOX SET CONTENTS: (1) CT Implantable Port (1) Cather (2) Catheter Locks (2) Scalpel (2) Introducer Needle (1) Guidewire (1) 10cc Syringe (1) 3cc Syringe (1) Peelable Introducer (2) Tunnelers (2) 22g Huber Needles (1 Straight, 1 Right Angle) (1) Blunt Tip Needle (1) Patient Information Packet (1) Patient Chart Sticker PEDIATRIC PEDIATRIC DIGNITY® 10F SPLIT CATH® III DASPC15P-XL 10F X 15CM SPLIT CATH® CATHETER, STRAIGHT 5/BOX DASPC18P-XL 10F X 18CM SPLIT CATH® CATHETER, STRAIGHT 5/BOX DASPC24P-XL 10F X 24CM SPLIT CATH® CATHETER, STRAIGHT 5/BOX BASIC SET CONTENTS: (1) Catheter (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Tunneler (1) Peelable Introducer (1) Adhesive Wound Dressing (2) End Caps (1) Patient ID Card Refer to the Table of Contents for Important Risk Information regarding this device. PEDIATRIC SPLIT CATH® Material Tip Design French Size Configuration Insertion Type Polyurethane Split Tip 10F Straight Antegrade 3 Pediatric
PEDIATRIC VASCU-PICC® TLS Refer to the Table of Contents for Important Risk Information regarding this device. CATHETER ONLY MD17011100 1.9F X 50CM SINGLE LUMEN VASCU-PICC® CATHETER ONLY 10/BOX MD17012600 2.6F X 50CM DUAL LUMEN VASCU-PICC® CATHETER ONLY 10/BOX BASIC SET WITHOUT OTN MD17021101 1.9F X 50CM SINGLE LUMEN VASCU-PICC® WITHOUT OTN 5/BOX MD17021121 1.9F X 20CM SINGLE LUMEN VASCU-PICC® WITHOUT OTN 5/BOX MD17022601 2.6F X 50CM DUAL LUMEN VASCU-PICC® WITHOUT OTN 5/BOX MD17022621 2.6F X 20CM DUAL LUMEN VASCU-PICC® WITHOUT OTN 5/BOX TEARAWAY INTRODUCER SET MD170111024S 1.9F X 50CM SINGLE LUMEN VASCU-PICC® W/2F TEARAWAY INTRODUCER SET 5/BOX MD170111224S 1.9F X 20CM SINGLE LUMEN VASCU-PICC® W/2F TEARAWAY INTRODUCER SET 5/BOX MD170126024S 2.6F X 50CM DUAL LUMEN VASCU-PICC® W/3F TEARAWAY INTRODUCER SET 5/BOX MD170126224S 2.6F X 20CM DUAL LUMEN VASCU-PICC® W/3F TEARAWAY INTRODUCER SET 5/BOX BASIC SET MD17011101 1.9F X 50CM SINGLE LUMEN VASCU-PICC® BASIC SET 5/BOX MD17011121 1.9F X 20CM SINGLE LUMEN VASCU-PICC® BASIC SET 5/BOX MD17012601 2.6F X 50CM DUAL LUMEN VASCU-PICC® BASIC SET 5/BOX MD17012621 2.6F X 20CM DUAL LUMEN VASCU-PICC® BASIC SET 5/BOX FULL NURSING KIT W/MAX BARRIER MRVSP19001 1.9F X 20CM SINGLE LUMEN TAPERLESS VASCU-PICC® FULL NUSING KIT W/MAX BARRIER 3/BOX MRVSP26001 2.6F X 50CM DUAL LUMEN TAPERLESS VASCU-PICC® FULL NURSING KIT W/MAX BARRIER 3/BOX PROCEDURE TRAY MR17019000 PICC PROCEDURE TRAY 3/BOX MR17019001 PEDIATRIC PICC PROCEDURE TRAY 3/BOX CATHETER ONLY CONTENTS: (1) Catheter W/Stylet (1) Adaptor W/Sideport (1I2) Needleless Connector(s) (1) Securement Device (1) Chart Sticker (1) Patient Information Packet BASIC SET WITHOUT OTN CONTENTS: (1) Catheter W/Stylet (1) Adaptor W/Sideport (1I2) Needleless Connector(s) (1) 10cc Syringe (1) Scalpel (1) Tourniquet (3) 2”X 2” Gauze (1) Tape Measure (1) Securement Device (1) Chart Sticker TEARAWAY INTRODUCER SET CONTENTS: (1) Catheter W/Stylet (1) Adaptor W/Sideport (1I2) Needleless Connector(s) (1) 24ga Safety IV Catheter (1) Guidewire (1) Tearaway Introducer (1) 10cc Syringe (1) Tourniquet (3) 2”X 2” Gauze (1) Tape Measure (1) Securement Device (1) Chart Sticker BASIC SET CONTENTS: (1) Catheter W/Stylet (1) Adaptor W/Sideport (1I2) Needleless Connector(s) (1) OTN Tearaway Introducer (1) 10cc Syringe (1) Tourniquet (3) 2”X 2” Gauze (1) Tape Measure (1) Securement Device (1) Chart Sticker FULL NURSING KIT W/MAX BARRIER CONTENTS: (1) Catheter W/Stylet (1) Adaptor W/Sideport (1) 22ga Introducer Needle (1) 22ga Safety IV Catheter (1) Guidewire (1) Scalpel (1) Tearaway Introducer (1) 5cc Syringe (1) 25ga Safety Hypodermic Needle (1) Tourniquet (3) Saline Syringes (3) 4”X 4” Gauze (3) 2”X 2” Gauze (1) Lidocaine (1) Filter Straw (1) Probe Cover W/Gel (1) Towel (1) Gown (1) Fenestrated Drape (1) Drape (3) Clear Chlorhexidine (1) Scissors (1) Forceps (1) Skin Protectant Swabstick (1) Alcohol Swabs (2) Face Masks (2) Tape Measures (1) Steri-Strips (1) Bouffant Cap (1) Securement Device (1) Needle Stick Pad (1) Needle Securement Device (1) Chart Sticker (1) Patient Information Packet PROCEDURE TRAY CONTENTS: (3) Pre-Filled Saline Syringes (1) Scalpel (1) Scissors (1) Clear Chlorhexidine (1) Tinted Chlorhexidine (1) Surgical Tape (1) Steri-Strips (2) CSR Wraps (1) Wound Dressing (1) Needle Stick Pad (1) Lidocaine (1) Filter Straw (1) Gloves (2) Tape Measures (2) Face Masks (1) Fenestrated Drape (2) Drapes (1) 5cc Syringe (1) 25ga Safety Hypodermic Needle (3) 4”X 4” Gauze (3) 2”X 2” Gauze (1) Bouffant Cap (1) XL Gown French Sizes 1.9F, 2.6F Lengths 20cm, 50cm Lumens Single, Dual 4
PEDIATRIC MST Refer to the Table of Contents for Important Risk Information regarding this device. Needle Sizes 22ga, 24ga Introducer Sizes 2F, 3F Wire Size .010 20cm, 40cm, 60cm, 80cm Wire Lengths 2F MST KITS DMR1902224S 2F X 2CM MST WITH 20CM NITINOL WIRE & IV CATHETER WITH 24GA SAFETY NEEDLE* 10/BOX DMR1902222S 2F X 2CM MST WITH 20CM NITINOL WIRE & IV CATHETER WITH 22GA SAFETY NEEDLE* 10/BOX DMR1902222 2F X 2CM MST WITH 20CM NITINOL WIRE & 22GA NEEDLE 10/BOX DMR1902424S 2F X 2CM MST WITH 40CM NITINOL WIRE & IV CATHETER WITH 24GA SAFETY NEEDLE* 10/BOX DMR1902422S 2F X 2CM MST WITH 40CM NITINOL WIRE & IV CATHETER WITH 22GA SAFETY NEEDLE* 10/BOX DMR1902422 2F X 2CM MST WITH 40CM NITINOL WIRE & 22GA NEEDLE 10/BOX DMR1902624S 2F X 2CM MST WITH 60CM STEEL WIRE & IV CATHETER WITH 24GA SAFETY NEEDLE* 10/BOX DMR1902622S 2F X 2CM MST WITH 60CM STEEL WIRE & IV CATHETER WITH 22GA SAFETY NEEDLE* 10/BOX DMR1902622 2F X 2CM MST WITH 60CM STEEL WIRE & 22GA NEEDLE 10/BOX 3F MST KITS DMR1903224S 3F X 3CM MST WITH 20CM NITINOL WIRE & IV CATHETER WITH 24GA SAFETY NEEDLE* 10/BOX DMR1903222S 3F X 3CM MST WITH 20CM NITINOL WIRE & IV CATHETER WITH 22GA SAFETY NEEDLE* 10/BOX DMR1903222 3F X 3CM MST WITH 20CM NITINOL WIRE & 22GA NEEDLE 10/BOX DMR1903424S 3F X 3CM MST WITH 40CM NITINOL WIRE & IV CATHETER WITH 24GA SAFETY NEEDLE* 10/BOX DMR1903422S 3F X 3CM MST WITH 40CM NITINOL WIRE & IV CATHETER WITH 22GA SAFETY NEEDLE* 10/BOX DMR1903422 3F X 3CM MST WITH 40CM NITINOL WIRE & 22GA NEEDLE 10/BOX DMR1903624S 3F X 3CM MST WITH 60CM STEEL WIRE & IV CATHETER WITH 24GA SAFETY NEEDLE* 10/BOX DMR1903622S 3F X 3CM MST WITH 60CM STEEL WIRE & IV CATHETER WITH 22GA SAFETY NEEDLE* 10/BOX DMR1903622 3F X 3CM MST WITH 60CM STEEL WIRE & 22GA NEEDLE 10/BOX ACCESSORIES DVS203 2F PEELABLE INTRODUCER 5/BOX DVS303 3F PEELABLE INTRODUCER 5/BOX DMR190040 0.010" X 40CM NITINOL GUIDEWIRE 10/BOX DMR190060 0.010" X 60CM STEEL GUIDEWIRE WITH HYDROPHILIC COATING 10/BOX DMRI19100801 0.010" X 80CM STEEL GUIDEWIRE WITH HYDROPHILIC COATING 10/BOX 2F MST SET CONTENTS: (1) Needle or IV Catheter with Needle* (1) Peelable Introducer (1) Guidewire 3F MST SET CONTENTS: (1) Needle or IV Catheter with Needle* (1) Peelable Introducer (1) Guidewire 5 Pediatric
PEDIATRIC
IMPORTANT RISK INFORMATION PEDIATRIC SPLIT CATH® Indications for Use: The Medcomp® Pediatric Split Cath® is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis and in pediatric, adolescent, and adult patients as determined by the prescribing physician. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the Subclavian and femoral vein. SPLIT CATH® III Indications for Use: The Medcomp® Split-Cath® III is indicated for use in attaining chronic (long-term) vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required. SPLIT CATH® III TRANSLUMBAR Indications for Use: The Medcomp Split Cath® III Catheter is indicated for use in attaining long term vascular access for hemodialysis and apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein insertion or inferior vena cava insertion. Translumbar insertion via inferior vena cava is indicated when all other access sites are identified as non-viable. PEDIATRIC SPLIT CATH®, SPLIT CATH® III, SPLIT CATH® III TRANSLUMBAR Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. TESIO® Indications for Use: The Medcomp® Tesio® Catheter is designed for long term hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian vein, the internal jugular is the preferred site. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. To maintain peak performance, it is recommended that this catheter be replaced after 18 months usage. To maintain peak performance of the Lock right Adapters, it is recommended that the adapters be replaced every 6 months. TITAN HD Indications for Use: The Medcomp® Titan HD is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion sites includes the subclavian vein as required. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. HEMO-FLOW® Indications for Use: The Medcomp® Hemo-Flow® Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are intended for femoral vein insertion. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. HEMO-FLOW® XF Indications for Use: The Medcomp® Hemo-Flow® XF Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions.
LONG TERM HEMODIALYSIS CATHETERS Pediatric Split Cath® Split Cath® III Tesio® Titan HD Hemo-Flow® Hemo-Flow® XF Hemo-Cath® LT Symetrex® HEMO-CATH® LT Indications for Use: The Medcomp® Hemo-Cath® LT Silicone Double Lumen Catheter can be utilized for long term implantation as well as temporary access for hemodialysis, hemoperfusion, or apheresis therapy. The cannula may be inserted via the Seldinger Technique due to the inner Teflon stylet, increasing linear strength. The stylet is removed after insertion, leaving the soft silicone cannula in the body. The flexible silicone make-up conforms well to the vessel anatomy, resulting in higher patient tolerance during extended use. Contraindications: The Subclavian Approach is NOT recommended for use with the Medcomp® Double Lumen Subclavian-Femoral Catheter in Hemodialysis or Hemoperfusion Procedures used for the management of acute poisoning or other situations in which a ventilator might be used due to risk of traumatic pneumothorax posing a dangerous complication for the patient. SYMETREX®/SYMETREX® WITH SIDEHOLES Indications for Use: The Symetrex® Long Term Hemodialysis Catheter and the Symetrex® Long Term Hemodialysis Catheter with Sideholes are symmetric tip dual lumen catheters designed for chronic hemodialysis and apheresis. They may be inserted percutaneously or by cut down. Catheters with greater than 37 cm implant length are indicated for femoral placement. Contraindications: Do not use these catheters in thrombosed vessels or for subclavian puncture when ventilator is in use. These devices are contraindicated whenever: Used for any purpose other than indicated in these instructions. The presence of other device related infection, or septicemia is known or suspected. End caps are not intended to be punctured with a needle. Severe chronic obstructive lung disease is present. Tissue factors in the localized area of device placement will prevent proper device stabilization and/or access. Venous thrombosis or vascular surgical procedures have occurred at the prospective placement site. Post irradiation of prospective insertion site. TESIO® REPAIR KIT Indications for Use: The Medcomp® Tesio® Catheter is designed for Long Term Hemodialysis and Apheresis. It may be inserted percutaneously, and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian vein, the internal jugular vein is the preferred site. Contraindications: This extension is not intended for any use other than that which is indicated. To maintain peak performance of the extension, it is recommended that the extensions be replaced every 6 months. MEDCOMP® REPAIR KIT Indications for Use: The Medcomp® Repair Kit is indicated for use in replacing damaged female luer connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. Repairs Medcomp® Catheters: Split Cath® Contraindications: Do not use to repair catheters other than those specified above. Do not replace connector if tubing is swollen or displays signs of degradation. This repair kit should not be used for any purpose other than indicated in these instructions. Refer to Instructions for Use provided with the product for complete instructions, warnings, precautions, and contraindications. Observe all instructions for use prior to using products. Failure to do so may result in patient complications. 8 Long Term
LONG TERM PEDIATRIC SPLIT CATH® & SPLIT CATH® III Material Tip Design French Sizes Configurations Insertion Type Polyurethane Split Tip 10F, 14F, 16F Antegrade Straight, Pre-Curved Double “D” Internal Lumen Design Splittable Lumens Hollow, Fast Track Stylet Arteriovenous Stylet Weave Refer to the Table of Contents for Important Risk Information regarding this device. 9 Long Term
LONG TERM PEDIATRIC SPLIT CATH® & SPLIT CATH® III 10F BASIC SET CONTENTS: (1) Catheter With Stylet (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Tunneler (1) Peelable Introducer (1) Adhesive Wound Dressing (2) End Caps (1) Patient ID Card 14F & 16F BASIC SET CONTENTS: (1) Catheter With Stylet (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Tunneler (1) Valved Peelable Introducer (1) Adhesive Wound Dressing (2) End Caps (1) Patient ID Card 14F & 16F BASIC SET WITH DUAL STYLET CONTENTS: (1) Catheter (2) Stylets (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Tunneler (1) Valved Peelable Introducer (1) Adhesive Wound Dressing (2) End Caps (1) Patient ID Card TRANSLUMBAR SET CONTENTS: (1) Catheter With Stylet (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Tunneler (1) Valved Peelable Introducer (1) Adhesive Wound Dressing (2) End Caps (1) Patient ID Card REPAIR KIT CONTENTS: (1) Luer Assembly (1) Scissors (1) Adhesive Backed Drape (3) Clamps (2) End Caps 10F BASIC SET DASPC15P-XL 10F X 15CM SPLIT CATH® CATHETER, STRAIGHT 5/BOX DASPC18P-XL 10F X 18CM SPLIT CATH® CATHETER, STRAIGHT 5/BOX DASPC24P-XL 10F X 24CM SPLIT CATH® CATHETER, STRAIGHT 5/BOX 14F BASIC SET DASPC24-3 14F X 24CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC28-3 14F X 28CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC32-3 14F X 32CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC36-3 14F X 36CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC40-3 14F X 40CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC55-3 14F X 55CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC24-3PC 14F X 24CM SPLIT CATH® III CATHETER, PRE-CURVED 5/BOX DASPC28-3PC 14F X 28CM SPLIT CATH® III CATHETER, PRE-CURVED 5/BOX DASPC32-3PC 14F X 32CM SPLIT CATH® III CATHETER, PRE-CURVED 5/BOX DASPC36-3PC 14F X 36CM SPLIT CATH® III CATHETER, PRE-CURVED 5/BOX 16F BASIC SET DASPC2416-3 16F X 24CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC2816-3 16F X 28CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC3216-3 16F X 32CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC3616-3 16F X 36CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC4016-3 16F X 40CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC5516-3 16F X 55CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC2416-3PC 16F X 24CM SPLIT CATH® III CATHETER, PRE-CURVED 5/BOX DASPC2816-3PC 16F X 28CM SPLIT CATH® III CATHETER, PRE-CURVED 5/BOX DASPC3216-3PC 16F X 32CM SPLIT CATH® III CATHETER, PRE-CURVED 5/BOX DASPC3616-3PC 16F X 36CM SPLIT CATH® III CATHETER, PRE-CURVED 5/BOX 14F BASIC SET W/ DUAL STYLETS DASPC24-3DS 14F X 24CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC28-3DS 14F X 28CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC32-3DS 14F X 32CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC36-3DS 14F X 36CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC40-3DS 14F X 40CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC55-3DS 14F X 55CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX 16F BASIC SET WITH DUAL STYLETS DASPC2416-3DS 16F X 24CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC2816-3DS 16F X 28CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC3216-3DS 16F X 32CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC3616-3DS 16F X 36CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC4016-3DS 16F X 40CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX DASPC5516-3DS 16F X 55CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX 14F TRANSLUMBAR SET ASPC40-3TL 14F X 40CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX ASPC55-3TL 14F X 55CM SPLIT CATH® III CATHETER, STRAIGHT 5/BOX ACCESSORIES DAST SPLIT CATH® III TUNNELER 5/BOX DAST-L SPLIT CATH® III LONG TUNNELER 5/BOX DRPK-01 MEDCOMP® REPAIR KIT 5/BOX 10
Retrograde Insertion LONG TERM TESIO® Refer to the Table of Contents for Important Risk Information regarding this device. Material Tip Design French Sizes Polyurethane Single Round 6.5F, 10F Insertion Type Retrograde Configuration Straight Independent Single Round Internal Lumen Design Football Cuff Two Independent, Round Lumens 6.5F BASIC SET CONTENTS: (2) Catheters (2) Introducer Needles (2) Guidewires (2) Tunneler (2) Peelable Introducers (1) Arterial Extension Set (Red) (1) Venous Extension Set (Blue) (2) Clamps (2) End Caps (1) Patient ID Card 10F BASIC SET CONTENTS: (2) Catheters (2) Introducer Needles (2) Guidewires (2) Tunneler (2) Football Tunneler (1) Dilator (2) Valved Peelable Introducers (1) Arterial Extension Set (Red) (1) Venous Extension Set (Blue) (2) Clamps (2) End Caps (1) Securement Device (1) Patient ID Card 6.5F BASIC SET PBF 6.5F X 29CM TESIO® CATHETER, CUFFS @ 12CM AND 15CM 5/BOX 10F BASIC SET DBFS-6 10F X 52CM TESIO® CATHETERS, CUFFS @ 18CM AND 21CM 5/BOX DBFR-6 10F X 52CM TESIO® CATHETERS, CUFFS @ 22CM AND 25CM 5/BOX DBFL-6 10F X 52CM TESIO® CATHETERS, CUFFS @ 27CM AND 30CM 5/BOX BFRD1070KD-A 10F X 70CM TESIO® CATHETERS, CUFFS @ 46CM AND 50CM 5/BOX 52CM BASIC SET DBFR1035KD-A 10F X 52CM TESIO® CATHETERS, CUFFS @ 18CM AND 22CM 5/BOX TESIO® REPAIR KIT PBF11A 6.5F TESIO® CATHETER ARTERIAL EXTENSION SET 10/BOX DBF11A 10F TESIO® CATHETER ARTERIAL EXTENSION SET 10/BOX PBF11V 6.5F TESIO® CATHETER VENOUS EXTENSION SET 10/BOX DBF11V 10F TESIO® CATHETER VENOUS EXTENSION SET 10/BOX DBF11AVS 10F TESIO® VENOUS/ARTERIAL EXTENSION SETS 10/BOX 52CM BASIC SET CONTENTS: (2) Catheters (2) Introducer Needles (2) Guidewires (2) Tunneler (2) Valved Peelable Introducers (1) Arterial Extension Set (Red) (1) Venous Extension Set (Blue) (2) Clamps (2) End Caps (1) Patient ID Card TESIO® ARTERIAL EXTENSION SET CONTENTS: (1) Arterial Extension Set (1) End Cap TESIO® VENOUS EXTENSION SET CONTENTS: (1) Venous Extension Set (1) End Cap TESIO® VENOUS/ARTERIAL EXTENSION SET CONTENTS: (1) Arterial Extension Set (1) Venous Extension Set (2) End Cap 11
LONG TERM TITAN HD Refer to the Table of Contents for Important Risk Information regarding this device. Material Tip Design French Size Configurations Insertion Type Polyurethane Step Tip 15.5F Antegrade Straight, Pre-Curved Double “D” Internal Lumen Design BASIC SET CONTENTS WITH SIDEHOLES: (1) Catheter With Stylet (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Tunneler (1) Adhesive Wound Dressing (1) End Caps BASIC SET THD155024 15.5F X 24CM TITAN HD CATHETER, STRAIGHT 5/BOX THD155028 15.5F X 28CM TITAN HD CATHETER, STRAIGHT 5/BOX THD155032 15.5F X 32CM TITAN HD CATHETER, STRAIGHT 5/BOX THD155036 15.5F X 36CM TITAN HD CATHETER, STRAIGHT 5/BOX THD155040 15.5F X 40CM TITAN HD CATHETER, STRAIGHT 5/BOX THD155055 15.5F X 55CM TITAN HD CATHETER, STRAIGHT 5/BOX DTHD155224 15.5F X 24CM TITAN HD CATHETER, PRE-CURVED 5/BOX DTHD155228 15.5F X 28CM TITAN HD CATHETER, PRE-CURVED 5/BOX DTHD155232 15.5F X 32CM TITAN HD CATHETER, PRE-CURVED 5/BOX DTHD155236 15.5F X 36CM TITAN HD CATHETER, PRE-CURVED 5/BOX 90 Degree Arterial Tip 90º Degree Tapered, Fast Track Stylet 15.5F Lumen 12
LONG TERM HEMO-FLOW® Refer to the Table of Contents for Important Risk Information regarding this device. Material Tip Design French Size Configurations Insertion Type Polyurethane Step Tip 14.5F Antegrade Straight, Pre-Curved Double “D” Internal Lumen Design HEMO-FLOW® XF Material Tip Design French Size Polyurethane Step Tip 15.5F Insertion Type Antegrade Configuration Straight Double “D” Internal Lumen Design BASIC SET CONTENTS: (1) Catheter (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Tunneler (1) Valved Peelable Introducer (1) Adhesive Wound Dressing (2) End Cap BASIC SET CONTENTS: (1) Catheter (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Tunneler (1) Valved Peelable Introducer (1) Adhesive Wound Dressing (2) End Caps BASIC SET DMC641499 15.5F X 20CM HEMO-FLOW® XF CATHETER, STRAIGHT 5/BOX DMC641500 15.5F X 22CM HEMO-FLOW® XF CATHETER, STRAIGHT 5/BOX DMC641501 15.5F X 24CM HEMO-FLOW® XF CATHETER, STRAIGHT 5/BOX DMC641502 15.5F X 28CM HEMO-FLOW® XF CATHETER, STRAIGHT 5/BOX DMC641503 15.5F X 32CM HEMO-FLOW® XF CATHETER, STRAIGHT 5/BOX DMC641504 15.5F X 36CM HEMO-FLOW® XF CATHETER, STRAIGHT 5/BOX DMC641505 15.5F X 40CM HEMO-FLOW® XF CATHETER, STRAIGHT 5/BOX DMC641506 15.5F X 55CM HEMO-FLOW® XF CATHETER, STRAIGHT 5/BOX BASIC SET DHFS 24 14.5F X 24CM HEMO-FLOW® CATHETER, STRAIGHT 5/BOX DHFS 28 14.5F X 28CM HEMO-FLOW® CATHETER, STRAIGHT 5/BOX DHFS 32 14.5F X 32CM HEMO-FLOW® CATHETER, STRAIGHT 5/BOX DHFS 36 14.5F X 36CM HEMO-FLOW® CATHETER, STRAIGHT 5/BOX DHFS 40 14.5F X 40CM HEMO-FLOW® CATHETER, STRAIGHT 5/BOX DHFS 55 14.5F X 55CM HEMO-FLOW® CATHETER, STRAIGHT 5/BOX HFS24PC 14.5F X 24CM HEMO-FLOW® CATHETER, PRE-CURVED 5/BOX HFS28PC 14.5F X 28CM HEMO-FLOW® CATHETER, PRE-CURVED 5/BOX HFS32PC 14.5F X 32CM HEMO-FLOW® CATHETER, PRE-CURVED 5/BOX HFS36PC 14.5F X 36CM HEMO-FLOW® CATHETER, PRE-CURVED 5/BOX 13
LONG TERM HEMO-CATH® LT Refer to the Table of Contents for Important Risk Information regarding this device. Longer Lengths Material Tip Design French Sizes Configurations Insertion Type Silicone Step Tip 8F, 12.5F Antegrade Straight, Pre-Curved Circle “C” Internal Lumen Design Silicone Material Angled Arterial Tip 8F BASIC SET DSL18P 8F X 18CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX DSL24P 8F X 24CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX 12.5F BASIC SET DMC101241 12.5F X 15CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX DMC101242 12.5F X 18CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX DMC101243 12.5F X 24CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX DSL28 12.5F X 28CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX DSL32 12.5F X 32CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX DSL28PC 12.5F X 28CM HEMO-CATH® LT CATHETER, PRE-CURVED 5/BOX DSL32PC 12.5F X 32CM HEMO-CATH® LT CATHETER, PRE-CURVED 5/BOX 12.5F FULL TRAY MCDLTSL28 12.5F X 28CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX MCDLTSL32 12.5F X 32CM HEMO-CATH® LT CATHETER, STRAIGHT 5/BOX MCDLTSL28PC 12.5F X 28CM HEMO-CATH® LT CATHETER, PRE-CURVED 5/BOX MCDLTSL32PC 12.5F X 32CM HEMO-CATH® LT CATHETER, PRE-CURVED 5/BOX 8F BASIC SET CONTENTS: (1) Catheter (1) Introducer Needle (1) Guidewire (1) Tunneler (1) Peelable Introducer (1) Syringe (1) Hemo-Cath® Hub Clip (1) Adhesive Wound Dressing (2) End Caps (1) Patient ID Card 12.5F BASIC SET CONTENTS: (1) Catheter (1) Introducer Needle (1) Guidewire (1) Scalpel (1) Peelable Introducer (1) Tunneler (1) Hemo-Cath® Hub Clip (1) Adhesive Wound Dressing (2) End Caps (1) Patient ID Card 12.5F FULL TRAY CONTENTS: (1) Catheter (1) Introducer Needle (1) Guidewire (1) Tunneler (1) Peelable Introducer (2) 5cc Syringe (2) 10cc Syringe (1) 5cc Lidocaine (1) Scalpel (3) 4” x 4” Gauze (1) Surgical Gloves (1) Fenestrated Drape (1) Hemostat (3) Hypodermic Needles (1) Chloraprep (1) 2-0 Silk Suture (1) Hemo-Cath® Hub Clip (1) Adhesive Wound Dressing (2) End Caps 14
LONG TERM SYMETREX® Refer to the Table of Contents for Important Risk Information regarding this device. Double “D” Internal Lumen Design Material Tip Design French Size Polyurethane Symmetrical 15.5F Insertion Type Antegrade Configuration Straight Symmetrical Tip Design High Flow Rate/Lower Pressure Designed to Preserve Access WITH SIDEHOLES BASIC SET MBPS019S 15.5F X 19CM SYMETREX® CATHETER* 5/BOX MBPS023S 15.5F X 23CM SYMETREX® CATHETER* 5/BOX MBPS028S 15.5F X 28CM SYMETREX® CATHETER* 5/BOX MBPS033S 15.5F X 33CM SYMETREX® CATHETER* 5/BOX MBNS037S 15.5F X 37CM SYMETREX® CATHETER 5/BOX MBNS042S 15.5F X 42CM SYMETREX® CATHETER 5/BOX SPORT PACK MSPS019S 15.5F X 19CM SYMETREX® CATHETER* 5/BOX MSPS023S 15.5F X 23CM SYMETREX® CATHETER* 5/BOX MSPS028S 15.5F X 28CM SYMETREX® CATHETER* 5/BOX MSPS033S 15.5F X 33CM SYMETREX® CATHETER* 5/BOX MSNS037S 15.5F X 37CM SYMETREX® CATHETER 5/BOX MSNS042S 15.5F X 42CM SYMETREX® CATHETER 5/BOX UPGRADE KIT MUPS019S 15.5F X 19CM SYMETREX® CATHETER 5/BOX MUPS023S 15.5F X 23CM SYMETREX® CATHETER 5/BOX MUPS028S 15.5F X 28CM SYMETREX® CATHETER 5/BOX MUPS033S 15.5F X 33CM SYMETREX® CATHETER 5/BOX WITHOUT SIDEHOLES BASIC SET MBPS019 15.5F X 19CM SYMETREX® CATHETER* 5/BOX MBPS023 15.5F X 23CM SYMETREX® CATHETER* 5/BOX MBPS028 15.5F X 28CM SYMETREX® CATHETER* 5/BOX MBPS033 15.5F X 33CM SYMETREX® CATHETER* 5/BOX MBNS037 15.5F X 37CM SYMETREX® CATHETER 5/BOX MBNS042 15.5F X 42CM SYMETREX® CATHETER 5/BOX BASIC SET CONTENTS: (1) Catheter (1) Introducer Needle (1) Guidewire (2) Dilator (1) Tunneler (1) Valved Peelable Introducer (1) Scalpel (2) End Caps (1) Patient ID Card (1) Patient Label *(2) Stylets SPORT PACK CONTENTS: (1) Catheter (2) Dilator (1) Tunneler (1) Valved Peelable Introducer (2) End Caps (1) Patient ID Card (1) Patient Label *(2) Stylets UPGRADE KIT CONTENTS: (1) Catheter (2) Stylets (2) End Caps (1) Patient ID Card (1) Patient Label 15
LONG TERM
IMPORTANT RISK INFORMATION SLX Indications for Use: The Medcomp® SLX Double Lumen Catheter can be utilized for temporary access for hemodialysis, hemoperfusion, or apheresis therapy. The cannula may be inserted via the Seldinger technique due to the inner Teflon stylet, increasing linear strength. The stylet is removed after insertion, leaving the soft silicone cannula in the body. The flexible silicone make-up conforms well to the vessel anatomy, resulting in higher patient tolerance during extended use. Contraindications: The Subclavian Approach is NOT recommended for use with the Medcomp® SLX Double Lumen Subclavian-Femoral Catheter in Hemodialysis or Hemoperfusion Procedures used for the management of acute poisoning or other situations in which a ventilator might be used due to risk of traumatic pneumothorax posing a dangerous complication for the patient. DUO-SPLIT® Indications for Use: The Medcomp® Duo-Split® Double Lumen Catheter is designed for acute hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian vein or femoral vein, the internal jugular vein is the preferred site. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not insert catheter in thrombosed vessels. HEMO-CATH® ST Indications for Use: The Medcomp® Hemo-Cath® ST Silicone Double Lumen Catheter can be utilized for temporary access for hemodialysis, hemoperfusion, or apheresis therapy. The cannula may be inserted via the Seldinger technique due to the inner Teflon stylet, increasing linear strength. The stylet is removed after insertion, leaving the soft silicone cannula in the body. The flexible silicone make-up conforms well to the vessel anatomy, resulting in higher patient tolerance during extended use. Contraindications: The Subclavian Approach is NOT recommended for use with the Medcomp® Hemo-Cath® ST Double Lumen Subclavian-Femoral Catheter in Hemodialysis or Hemoperfusion Procedures used for the management of acute poisoning or other situations in which a ventilator might be used due to risk of traumatic pneumothorax posing a dangerous complication for the patient. DUO-FLOW® 400XL Indications for Use: The Medcomp® Duo-Flow and Duo-Flow 400XL Double Lumen Catheters are designed for acute hemodialysis and apheresis. They may be inserted percutaneously and are ideally placed in the internal jugular vein. Although these catheters may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site. Contraindications: This catheter is intended for Short-Term vascular access only and should not be used for any purpose other than indicated in these instructions. DUO-FLOW® Indications for Use: The Medcomp® Duo-Flow® Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein or femoral vein as required. The curved Duo-Flow® Catheter is intended for internal jugular vein insertion. This catheter is indicated for a duration less than (30) days. For femoral placement, monitor catheter condition closely. Contraindications: This catheter is intended for Short-Term vascular access only and should not be used for any purpose other than indicated in these instructions. DUO-FLOW® SIDE X SIDE Indications for Use: The Duo-Flow® Side X Side double lumen catheter is intended for short-term central venous access for hemodialysis, apheresis and infusion. Contraindications: The catheter is not intended for any purpose other than indicated in these instructions. The Duo-Flow® Side X Side double lumen catheter is intended for short-term (less than 30 days) use. Do not use this catheter in thrombosed vessels or for subclavian puncture when a ventilator is in use. Do not use this catheter when: The patient’s body size is insufficient to accommodate the implanted device. The superficial or deep tissue will not permit adequate device stabilization and/or access. There are known physiological limitations that will not allow placement of the device. The patient has known or suspected allergies to any of the materials in the device. The patient has received significant radiation at the intended exit site or tunnel. The patient has severe chronic obstructive lung disease.
SHORT TERM HEMODIALYSIS CATHETERS SLX Duo-Split® Hemo-Cath® ST Duo-Flow® 400XL Duo-Flow® Duo-Flow® Side x Side Duo-Flow® Soft-Line® T-3® CT Tri-Flow Trio-CT® DUO-FLOW® SOFT-LINE® Indications for Use: The Medcomp® Duo-Flow® Soft-Line® and Raulerson/Duo-Flow® Double Lumen Internal Jugular Catheters are designed for acute hemodialysis and apheresis. They may be inserted percutaneously and are ideally placed in the jugular vein. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. T-3® CT Indications for Use: The Medcomp® T-3® CT Catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring. The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. Contraindications: This catheter is intended for short-term (less than 30 days) vascular access only and should not be used for any purpose other than indicated in these instructions. This device is also contraindicated: When the presence of device related infection, bacteremia, or septicemia is known or suspected. When the patient’s body size is insufficient to accommodate the size of the implanted device. When the patient is known or is suspected to be allergic to materials contained in the device. If the prospective insertion site has been previously irradiated. If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures. If local tissue factors may prevent proper device stabilization and/or access. TRI-FLOW Indications for Use: The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein or femoral vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days. Contraindications: This catheter is intended for Short-Term vascular access only and should not be used for any purpose other than indicated in these instructions. Do not insert catheter in thrombosed vessels. TRIO-CT® Indications for Use: The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring. The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. Contraindications: This catheter is intended for short-term (less than 30 days) vascular access only and should not be used for any purpose other than indicated in these instructions. This device is also contraindicated: When the presence of device related infection, bacteremia, or septicemia is known or suspected. When the patient’s body size is insufficient to accommodate the size of the implanted device. When the patient is known or is suspected to be allergic to materials contained in the device. If the prospective insertion site has been previously irradiated. If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures. If local tissue factors may prevent proper device stabilization and/or access. Refer to Instructions for Use provided with the product for complete instructions, warnings, precautions, and contraindications. Observe all instructions for use prior to using products. Failure to do so may result in patient complications. 18 Short Term
SHORT TERM SLX Material Silicone Tip Design Tapered Tip French Size 14F Configuration Straight Double “D” Internal Lumen Design 14F Lumen Silicone Material Tapered Tip 19 Short Term
SHORT TERM SLX BASIC SET CONTENTS: (1) Catheter with Stylet (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Peelable Introducer* (1) Adhesive Wound Dressing (2) End Caps (1) Hemo-Cath® Hub Clip (1) 2-0 Suture MAX BARRIER TRAY CONTENTS: (1) Catheter with Stylet (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Peelable Introducer* (1) Adhesive Wound Dressing (2) End Caps (1) Hemo-Cath Hub Clip (3) 4” x 4” Gauze (3) 2” x 2” Gauze (2) Chloraprep (1) 5cc Syringe (2) Pre-Filled Saline Syringes (1) 2-0 Silk Suture (2) Safety Hypodermic Needles (1) Hemostat (1) Fenestrated Drape (1) 5cc Lidocaine (1) Filter Straw (1) Surgical Gloves (1) Needle Stick Pad (1) Steri-Strips (2) Face Mask (1) Lidocaine/Saline Stickers (1) Surgical Tape (1) XL Gown (1) Bouffant Cap (1) Surgical Mask MAX BARRIER TRAY MC061422MB 14F X 15CM SLX CATHETER 4/BOX MC061423MB 14F X 20CM SLX CATHETER 4/BOX MC061424MB* 14F X 24CM SLX CATHETER 4/BOX MC061425MB* 14F X 30CM SLX CATHETER 4/BOX BASIC SET MC061402 14F X 15CM SLX CATHETER 5/BOX MC061403 14F X 20CM SLX CATHETER 5/BOX MC061404* 14F X 24CM SLX CATHETER 5/BOX MC061405* 14F X 30CM SLX CATHETER 5/BOX Refer to the Table of Contents for Important Risk Information regarding this device. 20
SHORT TERM DUO-SPLIT® Material Polyurethane Tip Design Split Tip French Size 13F Configurations Straight, Pre-Curved, IJ Double “D” Internal Lumen Design Split Tip Design Arteriovenous Weave with Dual Stylet Raulerson IJ Configuration BASIC SET CONTENTS: (1) Catheter with Dual Stylets (1) Introducer Needle (1) Guidewire (2) Dilators (1) Adhesive Wound Dressing (2) End Caps FULL TRAY CONTENTS: (1) Catheter with Dual Stylets (1) Introducer Needle (1) Guidewire (2) Dilators (1) Scalpel (1) Peelable Introducer (1) Adhesive Wound Dressing (2) End Caps (3) 4” x 4” Gauze (1) Chloraprep (1) 5cc Syringe (2) Pre-Filled Saline Syringes (1) 2-0 Silk Suture (3) Safety Hypodermic Needles (1) Hemostat (1) Fenestrated Drape (1) 5cc Lidocaine (1) Lidocaine/Saline Stickers (1) Filter Straw (1) Surgical Gloves (1) Needle Stick Pad BASIC SET DDSP134S 13F X 12CM DUO-SPLIT®, STRAIGHT 5/BOX DDSP136S 13F X 15CM DUO-SPLIT®, STRAIGHT 5/BOX DDSP138S 13F X 20CM DUO-SPLIT®, STRAIGHT 5/BOX DDSP139S 13F X 24CM DUO-SPLIT®, STRAIGHT 5/BOX DDSP130S 13F X 30CM DUO-SPLIT®, STRAIGHT 5/BOX DDSP134PS 13F X 12CM DUO-SPLIT®, PRE-CURVED 5/BOX DDSP136PS 13F X 15CM DUO-SPLIT®, PRE-CURVED 5/BOX DDSP138PS 13F X 20CM DUO-SPLIT®, PRE-CURVED 5/BOX DDSP139PS 13F X 24CM DUO-SPLIT®, PRE-CURVED 5/BOX DDSP134IJS 13F X 12CM DUO-SPLIT®, IJ 5/BOX DDSP136IJS 13F X 15CM DUO-SPLIT®, IJ 5/BOX DDSP138IJS 13F X 20CM DUO-SPLIT®, IJ 5/BOX DDSP139IJS 13F X 24CM DUO-SPLIT®, IJ 5/BOX FULL TRAY DSP136T 13F X 15CM DUO-SPLIT®, STRAIGHT 5/BOX DSP138T 13F X 20CM DUO-SPLIT®, STRAIGHT 5/BOX DSP139T 13F X 24CM DUO-SPLIT®, STRAIGHT 5/BOX DSP130T 13F X 30CM DUO-SPLIT®, STRAIGHT 5/BOX DSP134PT 13F X 12CM DUO-SPLIT®, PRE-CURVED 5/BOX DSP136PT 13F X 15CM DUO-SPLIT®, PRE-CURVED 5/BOX DSP138PT 13F X 20CM DUO-SPLIT®, PRE-CURVED 5/BOX DSP139PT 13F X 24CM DUO-SPLIT®, PRE-CURVED 5/BOX DSP134IJT 13F X 12CM DUO-SPLIT®, IJ 5/BOX DSP136IJT 13F X 15CM DUO-SPLIT®, IJ 5/BOX DSP138IJT 13F X 20CM DUO-SPLIT®, IJ 5/BOX DSP139IJT 13F X 24CM DUO-SPLIT®, IJ 5/BOX Refer to the Table of Contents for Important Risk Information regarding this device. 21
SHORT TERM HEMO-CATH® ST Material Silicone Tip Design Tapered Tip French Sizes 8F, 11.5F Configuration Straight Double “D” Internal Lumen Design Fast Track Stylet Silicone Material Tapered Tip 8F BASIC SET: (1) Catheter (1) Introducer Needle (1) Guidewire (1) Dilator (1) 10cc Syringe (1) Adhesive Wound Dressing (2) End Caps (1) Hemo-Cath® Hub Clip (1) Patient ID Card 11.5F BASIC SET CONTENTS: (1) Catheter with Stylet (1) Introducer Needle (1) Guidewire (2) Dilators (1) Adhesive Wound Dressing (2) End Caps (1) Hemo-Cath® Hub Clip (1) Patient ID Card FULL TRAY CONTENTS: (1) Catheter with Stylet (1) Introducer Needle (1) Guidewire (1) Dilator (1) Scalpel (1) Peelable Introducer (1) Adhesive Wound Dressing (2) End Caps (3) 4” x 4” Gauze (1) Chloraprep (1) 5cc Syringe (2) Pre-Filled Saline Syringes (1) 2-0 Silk Suture (3) Safety Hypodermic Needles (1) Hemostat (1) Fenestrated Drape (1) 5cc Lidocaine (1) Lidocaine/Saline Stickers (1) Filter Straw (1) Surgical Gloves (1) Needle Stick Pad 8F BASIC SET DSL12P 8F X 12CM HEMO-CATH® ST CATHETER, STRAIGHT 5/BOX 11.5F BASIC SET DSL12 11.5F X 12CM HEMO-CATH® ST, STRAIGHT 5/BOX DSL15 11.5F X 15CM HEMO-CATH® ST, STRAIGHT 5/BOX DSL20 11.5F X 20CM HEMO-CATH® ST, STRAIGHT 5/BOX DSL24 11.5F X 24CM HEMO-CATH® ST, STRAIGHT 5/BOX DSL27 11.5F X 27CM HEMO-CATH® ST, STRAIGHT 5/BOX 11.5F FULL TRAY MCDLTSL15 11.5F X 15CM HEMO-CATH® ST, STRAIGHT 5/BOX MCDLTSL20 11.5F X 20CM HEMO-CATH® ST, STRAIGHT 5/BOX MCDLTSL24 11.5F X 24CM HEMO-CATH® ST, STRAIGHT 5/BOX MCDLTSL27 11.5F X 27CM HEMO-CATH® ST, STRAIGHT 5/BOX Refer to the Table of Contents for Important Risk Information regarding this device. 22
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