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N/A AM0002

by Galemed Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number24710810112670 UDI-DI Date1 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
AM0002
Primary DI / UDI-DI
24710810112670
510(k) Number
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

Cleared under the same submission (K072755)

Other devices from Galemed Corp.

See all devices from Galemed Corp. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No