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UltraStream Chronic Dialysis Catheter Exchange Kit 32001524

by Argon Medical Devices, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886333222728 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2698-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2697-2014 FDA Class II initiated 5 Jun 2014
    • Terminated Z-2696-2014 FDA Class II initiated 5 Jun 2014

    UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
UltraStream Chronic Dialysis Catheter Exchange Kit
Generic Name
Double-lumen haemodialysis catheter, implantable
Model / Ref / Catalog
32001524
Primary DI / UDI-DI
00886333222728
510(k) Number
FDA Product Code
MSD
GMDN Term
Double-lumen haemodialysis catheter, implantable
Device Class
Class II
Regulation Number
876.5540
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No