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True Integral BS-602

by True Integral Inc 3 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number00860015383907 UDI-DI Date30 Mar 2026ListedStatusListed GUDID: not 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  • Withdrawn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
True Integral
Generic Name
Glucose monitoring system IVD, home-use
Model / Reference
BS-602
Primary DI / UDI-DI
00860015383907
FDA Product Code
NBW
GMDN Term
Glucose monitoring system IVD, home-use
Device Class
Class II
Regulation Number
862.1345
GUDID distribution status
Not in Commercial Distribution

Other devices from True Integral Inc

See all devices from True Integral Inc →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No