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AeroShield CPR Mask AM01BUS

by Aero Healthcare (Us), LLC

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09341394005242 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AeroShield CPR Mask
Generic Name
Cardiopulmonary resuscitation mask, single-use
Model / Ref / Catalog
AM01BUS
Primary DI / UDI-DI
09341394005242
FDA Product Code
KGB
GMDN Term
Cardiopulmonary resuscitation mask, single-use
Device Class
Class I
Regulation Number
868.5570
GUDID distribution status
In Commercial Distribution

Other devices from Aero Healthcare (Us), LLC

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Properties

  • Single Use
  • Premarket Exempt

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No