Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Safety Components

Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Safety Components
MAHURKAR - 8888103004HP

A sterile, flexible, triple-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access to: 1) conduct blood from a patient and return it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enable central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes three lumens, two dedicated to coaxial flow of blood for dialysis, and the third intended for independent IV access. Devices dedicated to catheter introduction/function may be included. This is a single-use device.

• Catheter Gauge: 12 French
• Length: 24 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NIE

Device Name: Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Device Class: 2

Physical State: N/A

Definition: Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5540

Third Party Flag: N

Medical Specialty: GU

Device Id: 10884521832794

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