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ONE-CARE 5016 ONE-CARE Safety Tube Holders,

by MediVena, LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810008212301 UDI-DI Date4 Sep 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  • Withdrawn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
One-Care
Generic Name
Blood collection tube holder/needle
Model / Ref / Catalog
5016 ONE-CARE Safety Tube Holders, 5016
Primary DI / UDI-DI
00810008212301
FDA Product Code
KST
GMDN Term
Blood collection tube holder/needle
Device Class
Class I
Regulation Number
864.9125
GUDID distribution status
In Commercial Distribution

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Properties

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

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No