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ketodoc Blood Glucose Plus B-Ketone Monitoring System TD-4141

by Rediston Limited 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00717931142227 UDI-DI Date9 Oct 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  • Withdrawn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
ketodoc Blood Glucose Plus B-Ketone Monitoring System
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use
Model / Reference
TD-4141
Description
Lancing device*1 Lancet*20pcs Blood glucose test strip*10pcs Ketone test strip*10pcs
Primary DI / UDI-DI
00717931142227
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 Rediston Limited

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