Acute Triple Lumen Catheter Kit,Curved Extensions
MAHURKAR - 8888345611
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
- Catheter Gauge: 12 French
- Length: 16 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 20884521006789
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521006782
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 10884521006782
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
GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.
GMDN ®. © GMDN Agency 2005-.