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First Aid Only M5042

by Acme United Corp.

First Aid Only M5042 is a cardiopulmonary resuscitation mask (FDA Class I; FDA product code BYP, Mouthpiece, Breathing) made by Acme United Corp., listed in FDA GUDID since 16 Dec 2022 (UDI-DI 00092265504201), registry data as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00092265504201 UDI-DI Date16 Dec 2022ListedStatusListed 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  • Withdrawn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
First Aid Only
Generic name
Cardiopulmonary resuscitation mask, single-use
Model / Ref / Catalog
M5042
Primary DI / UDI-DI
00092265504201
FDA product code
BYP
GMDN term
Cardiopulmonary resuscitation mask, single-use
Device class
Class I
Regulation number
868.5620
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiopulmonary resuscitation mask, single-use

Similar devices in this category

Other devices filed under Cardiopulmonary resuscitation mask, single-use.

Other devices from Acme United Corp.

See all devices from Acme United Corp. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
Other properties (12, all answered No)