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TRUEdraw CVS TRUEdraw Lancing Device

by Trividia Health, Inc. 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 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00050428167298 UDI-DI Date14 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TRUEdraw
Generic Name
Manual blood lancing device, reusable
Model / Ref / Catalog
CVS TRUEdraw Lancing Device, S3007-01
Primary DI / UDI-DI
00050428167298
510(k) Number
FDA Product Code
QRL
GMDN Term
Manual blood lancing device, reusable
Device Class
Class II
Regulation Number
878.4850
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: TRUEdraw® Lancing Device

Related devices

Cleared under the same submission (K221072)

Other devices from Trividia Health, Inc.

See all devices from Trividia Health, Inc. →

Properties

  • Over-the-Counter
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No