AccessGUDID - DEVICE: Niagara Slim-Cath catheter (00801741045646)

GUDID

Device Identifier (DI) Information

Brand Name: Niagara Slim-Cath catheter
Version or Model: 5755240
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5755240
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741045646
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: 12Fr Niagara ST 24cm Tray

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:	Yes
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?
37278	Double-lumen haemodialysis catheter, implantable	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MPB	CATHETER, HEMODIALYSIS, 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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 12 French
Length: 24 Centimeter
Device Size Text, specify: Size = Dual-Lumen

Device Record Status

Public Device Record Key: 992bcc9a-c0a0-48fb-9310-ab50107ee2bc
Public Version Date: June 30, 2025
Public Version Number: 4
DI Record Publish Date: November 11, 2015