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Biokit O2 AOJ-70B

by Biotricity, Inc.

Biokit O2 AOJ-70B is a Class II device made by Biotricity, Inc., listed in FDA GUDID since 24 Sep 2025 (UDI-DI B635BIOKIT0100), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB635BIOKIT0100 UDI-DI Date24 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Biokit O2
Generic name
Pulse oximeter
Model / reference
AOJ-70B
Primary DI / UDI-DI
B635BIOKIT0100
FDA product code
PGJ
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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Properties

  • Premarket exempt
  • Serial number
Other properties (13, all answered No)