Skip to content

Colli-Pee FV-5010

by Novosanis 2 variants

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 Number05404034700021 UDI-DI Date11 May 2023ListedStatusListed 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  • Withdrawn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
Colli-Pee
Generic Name
General specimen container IVD, additive/medium
Model / Ref / Catalog
Colli-Pee FV-5010, N00309
Primary DI / UDI-DI
05404034700021
FDA Product Code
NNK
GMDN Term
General specimen container IVD, additive/medium
Device Class
Class I
Regulation Number
864.3250
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No