H Chronic Catheter Sport Pack,Symmetrical Tip, Heparin Coating, Pre
Palindrome - 8888123411
Device Description
An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
Environmental Conditions
No Data Available
Device Sizes
- Length: 23 Centimeter
- Catheter Gauge: 14.5 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NYU
Device Name: Catheter, Hemodialysis, Implanted, Coated
Device Class: 2
Physical State: Tube of plastic
Definition: Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Circulates blood from the vascular system to a hemodialysis machine. The coatings on the catheter reduce infection or thrombosis by local affects on the blood
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Central venous system
Regulation Number: 876.5540
Third Party Flag: N
Medical Specialty: GU
Device Identifiers
Device Id: 10884521056602
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 20884521056609
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521056602
Package Quantity: 5
Package Discontinue Date: 4/29/2020 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: PACK_OR_INNER_PACK
