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CareSens S Fit BT 8000-10973

by Agamatrix, Inc.

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 Number10385540109732 UDI-DI Date30 Nov 2025ListedStatusListed 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  • Withdrawn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
CareSens S Fit BT
Generic Name
Glucose monitoring system IVD, home-use
Model / Reference
8000-10973
Primary DI / UDI-DI
10385540109732
510(k) Number
FDA Product Code
NBW
GMDN Term
Glucose monitoring system IVD, home-use
Device Class
Class II
Regulation Number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K193590)

Other devices from Agamatrix, Inc.

See all devices from Agamatrix, Inc. →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No