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Ozeri BP8H

by Commonpath LLC

Ozeri BP8H is a Class II device made by Commonpath LLC, listed in FDA GUDID since 15 May 2017 (UDI-DI 00815817012456), 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 Number00815817012456 UDI-DI Date15 May 2017ListedStatusListed 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  • Withdrawn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
Automatic-inflation electronic sphygmomanometer, portable, finger
Model / reference
BP8H
Primary DI / UDI-DI
00815817012456
FDA product code
DXN
GMDN term
Automatic-inflation electronic sphygmomanometer, portable, finger
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Other devices from Commonpath LLC

See all devices from Commonpath LLC →

Properties

  • Lot / batch number
Other properties (14, all answered No)