RT Repair Kit,Reverse
Palindrome - 8888541128
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
- Catheter Gauge: 15 French
- Length: 28 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NFK
Device Name: Kit, Repair, Catheter, Hemodialysis
Device Class: 2
Physical State: Hemodialysis Tray
Definition: Hemodialysis Tray
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Hemodialysis Tray
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: Hemodialysis Tray
Regulation Number: 876.5540
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 10884521135550
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