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LIVE TULA Lancing Device TD-5011

by Tula Health, Inc.

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 Number00850065253305 UDI-DI Date3 Dec 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  • Withdrawn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

Trade Name
LIVE TULA Lancing Device
Generic Name
Manual blood lancing device, reusable
Model / Reference
TD-5011
Primary DI / UDI-DI
00850065253305
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

Related devices

Cleared under the same submission (K221419)

Other devices from Tula Health, Inc.

Properties

  • Lot / Batch Number

Other properties (13)

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