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AirLife™ AM-1000

by Airlife, Inc.

AirLife™ AM-1000 is a Class I device made by Airlife, Inc., listed in FDA GUDID since 7 Mar 2025 (UDI-DI 10889483596128), 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 Number10889483596128 UDI-DI Date7 Mar 2025ListedStatusListed 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  • Withdrawn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
AirLife™
Generic name
Vortex oxygen face mask
Model / Ref / Catalog
AM-1000
Primary DI / UDI-DI
10889483596128
FDA product code
BYG
GMDN term
Vortex oxygen face mask
Device class
Class I
Regulation number
868.5580
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vortex oxygen face mask

Other devices from Airlife, Inc.

See all devices from Airlife, Inc. →

Properties

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