FDA.reportPublic FDA data

BreathePal Bilevel

Primary DI
04712978252065
Brand
BreathePal Bilevel
Company
Compal Electronics, Inc.
Model
GFM50-MD2201
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MNSVentilator, Continuous, Non-Life-Supporting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252078000BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.2026-03-17MNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712978252065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712978252065047129782520654712978252065

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Regulatory Flags#

DUNS number
656127743
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712978252058AblatePal Radiofrequency Ablation SystemHFM01-MD22022026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08401934313389ResScanRESMED CORP.MNS2023-02-24
08401934313396ResScanRESMED CORP.MNS2023-02-24
00606959049024DreamMapper Web (DM)Respironics, Inc.MNS2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNS2020-10-16
00606959049048DreamMapper Web (APAC)Respironics, Inc.MNS2020-10-16
00606959049055DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2020-10-16
00606959049086DreamMapper App iOSRespironics, Inc.MNS2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNS2020-10-16
00606959049840Care OrchestratorRespironics, Inc.MNS2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNS2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNS2020-09-23
00606959052093DreamMapper Web (DM)Respironics, Inc.MNS2020-05-20
00606959053519DreamMapper Web (EMEA)Respironics, Inc.MNS2020-05-20
00606959033344Li Ion Battery, Ventilation, JapanRespironics, Inc.MNS2019-06-05
00606959049871DreamMapper Web (APAC)Respironics, Inc.MNS2019-04-19
00606959049925DreamMapper Android China Instance v 2.11Respironics, Inc.MNS2019-04-19
00606959049888DreamMapper Web China Instance v 2.11Respironics, Inc.MNS2019-04-18
00606959049895DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2019-04-18
00606959049901DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNS2019-04-18
00606959049918DreamMapper Mobile App Android (APAC)Respironics, Inc.MNS2019-04-18
00606959033306BatteryRespironics, Inc.MNS2019-03-04
00606959054820EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959054837EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959053984Care Orchestrator EssenceRespironics, Inc.MNS2018-12-20
00606959054790Care OrchestratorRespironics, Inc.MNS2018-12-10
00606959054189DreamMapperRespironics, Inc.MNS2018-10-30
00606959054196DreamMapperRespironics, Inc.MNS2018-10-30
00606959054202DreamMapperRespironics, Inc.MNS2018-10-30
00606959054219DreamMapperRespironics, Inc.MNS2018-10-30
00606959054226DreamMapperRespironics, Inc.MNS2018-10-30