AccessGUDID - DEVICE: Duet Long-Term Hemodialysis Catheter System (00801741011979)

GUDID

Device Identifier (DI) Information

Brand Name: Duet Long-Term Hemodialysis Catheter System
Version or Model: 5223280
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5223280
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741011979
Issuing Agency: GS1
Commercial Distribution End Date: September 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: DUET HEMODIALYSIS CATH, 10 FR. SL 28A/31V

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
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
MSD	Catheter, hemodialysis, 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
Length: 31 Centimeter
Catheter Gauge: 10 French
Length: 28 Centimeter

Device Record Status

Public Device Record Key: b98cbf48-4894-4b2b-8618-11171379fc0e
Public Version Date: April 17, 2024
Public Version Number: 4
DI Record Publish Date: May 06, 2015