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ONE-CARE Pen Needles

by MediVena, LLC 7 variants

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 Number00810008214275 UDI-DI Date20 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Autoinjector needle
Model / Ref / Catalog
3016-ONE-CARE Pen Needles 31G x 4mm, Sky Blue, 100/bx, 100bx/cs, 3016
Primary DI / UDI-DI
00810008214275
FDA Product Code
FMI
GMDN Term
Autoinjector needle
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 31 Gauge
Length — 4 Millimeter

Other devices from MediVena, LLC

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Implantable: No
  • Contains Latex: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No