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BreathePal Bilevel GFM50-MD2201

by Compal Electronics, Inc.

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 Number04712978252065 UDI-DI Date13 May 2026ListedStatusListed 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  • Withdrawn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

Trade Name
BreathePal Bilevel
Generic Name
Portable electric ventilator
Model / Reference
GFM50-MD2201
Primary DI / UDI-DI
04712978252065
510(k) Number
FDA Product Code
MNS
GMDN Term
Portable electric ventilator
Device Class
Class II
Regulation Number
868.5895
GUDID distribution status
In Commercial Distribution

Other devices from Compal Electronics, Inc.

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No