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One-Care Opti+

by MediVena, LLC 2 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 Number00810008212226 UDI-DI Date11 Sep 2026ListedStatusListed 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  • Withdrawn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
Blood lancet, single-use
Model / Ref / Catalog
1050 ONE-CARE OPTI+ Adjustable Safety Lancets Top Button Activated 28G, 1050
Primary DI / UDI-DI
00810008212226
510(k) Number
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 — 28 Gauge

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