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Soft-Cell PC Dialysis Catheter Kit 12.5 F x 12 cm 5533120

by Bard Access Systems, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801741012389 UDI-DI Date29 May 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Soft-Cell PC Dialysis Catheter Kit 12.5 F x 12 cm
Generic Name
Double-lumen haemodialysis catheter, implantable
Model / Ref / Catalog
5533120
Primary DI / UDI-DI
00801741012389
FDA Product Code
LFJ
GMDN Term
Double-lumen haemodialysis catheter, implantable
Device Class
Class II
Regulation Number
876.5540
GUDID distribution status
Not in Commercial Distribution
Size
Length — 12 Centimeter
Catheter Gauge — 12.5 French

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Properties

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

Other properties (7)

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