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BLE Smart® Test Strips BLE-TS50-FDA

by Entra Health Systems GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852668007019 UDI-DIDate23 Feb 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
BLE Smart® Test Strips
Generic Name
Glucose monitoring system IVD, home-use
Model / Reference
BLE-TS50-FDA
Primary DI / UDI-DI
00852668007019
FDA Product Code
CGA
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 — 0.5 Microliter

Other devices from Entra Health Systems

Properties

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

Other properties (9)

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