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SafetyO2 AM-OXY-FP

by Groman Inc.

SafetyO2 AM-OXY-FP is a non-rebreathing oxygen face mask (FDA Class I; FDA product code KGB, Mask, Oxygen, Non-Rebreathing) made by Groman Inc., listed in FDA GUDID since 1 Mar 2023 (UDI-DI 00817494020700), 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 Number00817494020700 UDI-DI Date1 Mar 2023ListedStatusListed 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  • Withdrawn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
SafetyO2
Generic name
Non-rebreathing oxygen face mask
Model / reference
AM-OXY-FP
Primary DI / UDI-DI
00817494020700
FDA product code
KGB
GMDN term
Non-rebreathing oxygen face mask
Device class
Class I
Regulation number
868.5570
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Non-rebreathing oxygen face mask

Similar devices

Other devices filed under FDA product code KGB (Mask, Oxygen, Non-Rebreathing).

Other devices from Groman Inc.

Properties

  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)