FDA.reportPublic FDA data

Home CPAP unit

Definition
A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.
GUDID devices
887
Last updated
2025-10-01 23:40:28

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00619498395170AIR 11RESMED PTY LTD390002021-03-31
00606959424036DreamStationRespironics, Inc.DreamStation CPAP with Humidifier, US2016-08-21
00606959424067DreamStationRespironics, Inc.DreamStation CPAP, US2016-08-21
00606959424081DreamStationRespironics, Inc.DreamStation CPAP w/Humidifier, w/Heated Tube, US2016-08-21
00606959424104DreamStationRespironics, Inc.DreamStation CPAP Pro with Humidifier, US2016-08-21
00606959424128DreamStationRespironics, Inc.DreamStation CPAP Pro, US2016-08-21
00606959424135DreamStationRespironics, Inc.DreamStation CPAP Pro w/Humid w/Heated Tube, US2016-08-21
00606959424159DreamStationRespironics, Inc.DreamStation Auto CPAP with Humidifier, US2016-08-21
00606959424173DreamStationRespironics, Inc.DreamStation Auto CPAP, US2016-08-21
00606959424197DreamStationRespironics, Inc.DreamStation Auto CPAP w/Humid w/Heated Tube, US2016-08-21
06948538363553/BMC Medical Co., Ltd.G46002025-06-09
06948538363560/BMC Medical Co., Ltd.G460022025-06-09
04719893332810APEXWellell Inc. 9S-0072012024-08-15
04719893333091APEXWellell Inc.9S-0057202024-08-15
M9505050170TranscendSOMNETICS INTERNATIONAL, INC.Micro PureFresh2024-01-31
00850003157207Eclipse Vent Diffuser KitBLEEP, LLC100668 2023-08-21
10850003157211Eclipse Vent FilterBLEEP, LLC100671 2023-08-21
16948538362676Water chamberBMC Medical Co., Ltd.WT-B12023-08-21
09420012421616Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHC244JHU2023-07-06
09420012421647Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHC242JHU2023-07-06
16948538364281Blank SD Card for Pap DevicesBMC Medical Co., Ltd.P600-16G2023-04-07
06948538363362Auto CPAP SystemBMC Medical Co., Ltd.M1 Mini2023-03-03
16948538362997Carrying CaseBMC Medical Co., Ltd.CC-E12023-03-03
16948538363376Filter CapBMC Medical Co., Ltd.FC-E12023-03-03
16948538363383AC/DC Power AdapterBMC Medical Co., Ltd.AD-E32023-03-03
16948538363390Display ShellBMC Medical Co., Ltd./2023-03-03
16948538362768KnobBMC Medical Co., Ltd.NA2022-09-15
00850003157191Eclipse Magnetic Port Replacement PackBLEEP, LLC1006592022-10-11
10850003157174Eclipse Vent Diffuser KitBLEEP, LLC1006612022-10-11
10850003157181Eclipse Vent Filter Replacement PackBLEEP, LLC1006622022-10-11
16948538362751/BMC Medical Co., Ltd.FC-C12022-09-22
16948538362911/BMC Medical Co., Ltd.WL-5002022-09-22
16948538362843/BMC Medical Co., Ltd.AF-B22022-09-22
06948538363270Luna®BMC Medical Co., Ltd.LG2A002022-08-29
06948538363287Luna®BMC Medical Co., Ltd.LG20002022-08-29
06948538363294Luna®BMC Medical Co., Ltd.LG2A002022-08-29
06948538363300Luna®BMC Medical Co., Ltd.LG20002022-08-29
06948538363317Luna®BMC Medical Co., Ltd.LG36002022-08-29
06948538363348Luna®BMC Medical Co., Ltd.LG35002022-08-29
06948538365618Luna®BMC Medical Co., Ltd.LG36002022-08-29
169485383626453BBMC Medical Co., Ltd.AD-NJ2022-08-29
169485383626523BBMC Medical Co., Ltd.CC-C1-3BM2022-08-29
169485383626693BBMC Medical Co., Ltd.AD-B22022-08-29
06948538363324Luna®BMC Medical Co., Ltd.LG35002022-08-26
06948538363331Luna®BMC Medical Co., Ltd.LG36002022-08-26
06948538365625Luna®BMC Medical Co., Ltd.LG35002022-08-26
00850003157047Bleep Dreamway BLEEP, LLC1003802022-08-23
00850003157078Vent diffuser kit - Quarterly supplyBLEEP, LLC1005932022-08-23
00850003157108Vent Diffuser kitBLEEP, LLC1006042022-08-23
00850003157139Eclipse Magnetic FrameBLEEP, LLC1005912022-08-23
00850003157146Tube Management SystemBLEEP, LLCTUBEMGMT2022-08-23
008500031571536’ gray standard CPAP tubeBLEEP, LLC TUB0062022-08-23
00850003157160Durable CPCP slim tube - 6' BLEEP, LLCTUB006SS2022-08-23
00860004821403Bleep Dreamway BLEEP, LLC1005862022-08-23
10850003157068HMEBLEEP, LLC1005922022-08-23
10850003157082Vent filter 24 packBLEEP, LLC1005952022-08-23
10850003157099Vent diffuser kit 24 packBLEEP, LLC1006052022-08-23
10850003157129Eclipse Starter KitBLEEP, LLC1005892022-08-23
20850003157119Bleep HalosBLEEP, LLC1005902022-08-23
00619498373826AIRSENSERESMED PTY LTD373822022-06-03
00606959063082DreamStation 2Respironics, Inc.DreamStation 2 Auto CPAP Advanced w/ Hum2021-10-27
00606959063228DreamStation 2Respironics, Inc.DreamStation 2 CPAP w/ Humidifier/Cell/B2021-10-27
00619498388288AirMini 20W AC AdapterRESMED PTY LTD388282020-07-14
00619498390014AIR 11RESMED LIMITED390012021-06-25
00619498390021AIR 11RESMED LIMITED390022021-06-25
00619498390038AIR 11RESMED LIMITED390032021-06-25
00619498390045AIR 11RESMED LIMITED390042021-06-25
00619498390052AIR 11RESMED LIMITED390052021-06-25
00619498393022AIR 11RESMED LIMITED393022021-06-25
00619498393039AIR 11RESMED LIMITED393032021-06-25
00619498393046AIR 11RESMED LIMITED393042021-06-25
00619498393053AIR 11RESMED LIMITED393052021-06-25
00619498393060AIR 11RESMED LIMITED393062021-06-25
00619498393077AIR 11RESMED LIMITED393072021-06-25
00850003157030Dreamway clinicalBLEEP, LLC1003852021-05-10
00850003157054Dreamway connector kitBLEEP, LLC1005652021-05-10
00619498003273CLIMATELINEAIR 11RESMED LIMITED391022021-03-31
00619498391004HUMIDAIR11 STANDARDRESMED LIMITED391002021-03-31
00619498392056AIR 11RESMED LIMITED392052021-03-31
00619498392209AIR 11RESMED LIMITED392202021-03-31