Acute and Chronic Catheter Repair Kit,Palindrome Chronic Care and all MAHURKAR Acute and Chronic Care Catheters


Product Overview

Acute and Chronic Catheter Repair Kit,Palindrome Chronic Care and all MAHURKAR Acute and Chronic Care Catheters
NA - 8888200001


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

No Data Available


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 Identifiers

Device Id: 10884521056282

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


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