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MyGlucoHealth® BT Meter Kit MGH-BT1

by Entra Health Systems

Listed FDA GUDID listing, not in commercial distribution

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 Number00850081003007 UDI-DI Date27 Jan 2017ListedStatusListed GUDID: not 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  • Withdrawn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
MyGlucoHealth® BT Meter Kit
Generic Name
Glucose monitoring system IVD, home-use
Model / Reference
MGH-BT1
Primary DI / UDI-DI
00850081003007
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
Not in Commercial Distribution
Size
Total Volume — 0.3 Microliter

Other devices from Entra Health Systems

Properties

  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No