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Bf 64007

by Allied Medical LLC

Bf 64007 is a non-rebreathing oxygen face mask (FDA Class I; FDA product code BYG, Mask, Oxygen) made by Allied Medical LLC, listed in FDA GUDID since 11 Oct 2024 (UDI-DI 00026072023013), 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 Number00026072023013 UDI-DI Date11 Oct 2024ListedStatusListed 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  • Withdrawn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
Bf
Generic name
Non-rebreathing oxygen face mask
Model / reference
64007
Primary DI / UDI-DI
00026072023013
FDA product code
BYG
GMDN term
Non-rebreathing oxygen face mask
Device class
Class I
Regulation number
868.5580
GUDID distribution status
In Commercial Distribution

Related devices

Category: Non-rebreathing oxygen face mask

Similar devices

Other devices filed under FDA product code BYG (Mask, Oxygen).

Other devices from Allied Medical LLC

See all devices from Allied Medical LLC →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)