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ONE-CARE OPTI Safety Lancets

by MediVena, LLC 14 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 Number00810008215975 UDI-DI Date11 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  • Withdrawn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

Generic Name
Blood lancet, single-use
Model / Ref / Catalog
1045 ONE-CARE OPTI Safety Lancets Top Button Activated 25G x 2mm, Purple, Pink, 1045
Primary DI / UDI-DI
00810008215975
FDA Product Code
FMK
GMDN Term
Blood lancet, single-use
Device Class
Class II
Regulation Number
878.4850
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 25 Gauge
Length — 2.0 Millimeter

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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