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ONE-CARE Insulin Syringes

by MediVena, LLC 16 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00810008218259 UDI-DI Date15 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Insulin syringe/needle, basic
Model / Ref / Catalog
2291 ONE-CARE Insulin Syringes 0.3ml|31Gx8mm, Blister Pack, 100/bx, 30bx/cs, 2291
Primary DI / UDI-DI
00810008218259
510(k) Number
FDA Product Code
FMF, FMI
GMDN Term
Insulin syringe/needle, basic
Device Class
Class II
Regulation Number
880.5860, 880.5570
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 0.3 Milliliter
Length — 8 Millimeter
Needle Gauge — 31 Gauge

Related devices

Cleared under the same submission (K242434)

Show all (12)

Other devices from MediVena, LLC

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Properties

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

Other properties (7)

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