Precision H Chronic Catheter Kit,Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 33 cm

Precision H Chronic Catheter Kit,Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 33 cm
Palindrome - 8888145046CP

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.

• Catheter Gauge: 14.5 French
• Length: 33 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 10884521158122

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: 20884521158129

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521158122

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK