AccessGUDID - DEVICE: Flexxicon II Short-Term Dialysis Catheter Kit (00801741101052)

GUDID

Device Identifier (DI) Information

Brand Name: Flexxicon II Short-Term Dialysis Catheter Kit
Version or Model: 5524120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5524120
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741101052
Issuing Agency: GS1
Commercial Distribution End Date: September 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: Flexxicon II Dialysis Catheter Kit 12F x 12.5cm (Pre-Curved) (Short-term) (Dual-Lumen)

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":	No
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
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 12 French
Length: 12.5 Centimeter

Device Record Status

Public Device Record Key: 231b2ca1-c67e-4b61-b125-74cf3ca607e5
Public Version Date: September 26, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2015