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ONE-CARE Safety Lancets

by MediVena, LLC 7 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 Number00810008210147 UDI-DI Date23 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  • Withdrawn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
Manual blood lancing device, single-use
Model / Ref / Catalog
1106 ONE-CARE Safety Lancets 21G x 2.4mm, ExtraFlow, Yellow, 100/bx, 20bx/cs, 1106
Primary DI / UDI-DI
00810008210147
510(k) Number
FDA Product Code
FMK
GMDN Term
Manual blood lancing device, single-use
Device Class
Class II
Regulation Number
878.4850
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 21 Gauge
Length — 2.4 Millimeter

Related devices

Cleared under the same submission (K222376)

Show all (12)

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