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AF541

by Respironics Inc. 83 variants

AF541 (1121066) is a Class II device made by Respironics Inc., listed in FDA GUDID since 2 Sep 2016 (UDI-DI 00606959024526), 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 Number00606959024526 UDI-DI Date2 Sep 2016ListedStatusListed 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  • Withdrawn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

Generic name
CPAP/BPAP face mask, single-use
Model / Ref / Catalog
AF541 Mask EE, Leak 2 with 4 Point Headgear, Small, 1121066
Primary DI / UDI-DI
00606959024526
FDA product code
BZD
GMDN term
CPAP/BPAP face mask, single-use
Device class
Class II
Regulation number
868.5905
GUDID distribution status
In Commercial Distribution

Related devices

Category: CPAP/BPAP face mask, single-use

Similar devices in this category

Other devices filed under CPAP/BPAP face mask, single-use.

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)