AccessGUDID - DEVICE: UltraStream Chronic Dialysis Catheter Exchange Kit (00886333222742)

GUDID

Device Identifier (DI) Information

Brand Name: UltraStream Chronic Dialysis Catheter Exchange Kit
Version or Model: 32001532
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 32001532
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333222742
Issuing Agency: GS1
Commercial Distribution End Date: December 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: UltraStream Chronic Dialysis Catheter Exchange Kit 15.5F x 32cm

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?
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 [?]
K102043	000

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
Device Size Text, specify: 15.5F x 32cm

Device Record Status

Public Device Record Key: 2c8e14a9-e196-48ef-bf73-f2fb943d6c3f
Public Version Date: December 10, 2024
Public Version Number: 5
DI Record Publish Date: September 20, 2016