AccessGUDID - DEVICE: Power-Trialysis Alphacurve catheter (00801741066016)

GUDID

Device Identifier (DI) Information

Brand Name: Power-Trialysis Alphacurve catheter
Version or Model: 5653120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5653120
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741066016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: 13Fr Trialysis Alphacurve 12.5cm Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61629	Triple-lumen haemodialysis catheter	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NIE	CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 13 French
Length: 12.5 Centimeter
Device Size Text, specify: Size = Triple-Lumen
Device Size Text, specify: Diameter = 4.3 millimetre (mm)

Device Record Status

Public Device Record Key: 10d3f309-363d-4b55-908f-911e501d5e53
Public Version Date: June 30, 2025
Public Version Number: 3
DI Record Publish Date: November 06, 2015