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Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag 5003

by Dynarex Corp.

Listed FDA GUDID listing, no authorization on record

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 Number00840117351684 UDI-DI Date31 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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
Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag
Generic Name
Single-administration urethral catheterization kit, single-use
Model / Reference
5003
Primary DI / UDI-DI
00840117351684
FDA Product Code
FCN
GMDN Term
Single-administration urethral catheterization kit, single-use
Device Class
Class II
Regulation Number
876.5250
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No