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SureMediks B-ketone & blood glucose monitoring system TD-4279D

by Rasimo Systems LLC

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00199284201354 UDI-DI Date5 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SureMediks B-ketone & blood glucose monitoring system
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use
Model / Reference
TD-4279D
Primary DI / UDI-DI
00199284201354
FDA Product Code
NBW
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use
Device Class
Class II
Regulation Number
862.1345
GUDID distribution status
In Commercial Distribution

Other devices from Rasimo Systems LLC

Properties

  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (11)

  • 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
  • Manufacturing Date: No