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Ozeri TH1-BL

by Commonpath LLC

Ozeri TH1-BL is a Class II device made by Commonpath LLC, listed in FDA GUDID since 1 Nov 2021 (UDI-DI 00815817014153), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815817014153 UDI-DI Date1 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ozeri
Generic name
Infrared patient thermometer, ear
Model / reference
TH1-BL
Primary DI / UDI-DI
00815817014153
FDA product code
FLL
GMDN term
Infrared patient thermometer, ear
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).

Other devices from Commonpath LLC

See all devices from Commonpath LLC →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)