FDA.reportPublic FDA data

Home BPAP 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 bi-level positive airway pressure (BPAP) during spontaneous respiration for adult/child (non-infant) patients affected by obstructive sleep apnoea (OSA) and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (COPD)]. It is a small desktop unit with controls, and may include a built-in humidifier. The device is intended for use in the home but may also be used in healthcare facilities.
GUDID devices
316
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00619498390243AIRCURVE11 VPAP TXRESMED PTY LTD390242025-01-24
00619498512027AirCurve 11 ST-ARESMED PTY LTD512022026-04-21
00619498512034AirCurve 11 ST-ARESMED PTY LTD512032026-04-21
00619498512157AirCurve 11 ST-ARESMED PTY LTD512152026-04-21
06948538362594Water ChamberBMC Medical Co., Ltd.WT-D12022-08-26
06948538362600PM2.5 FilterBMC Medical Co., Ltd.PF-D1/PF-D2/PF-D32022-08-26
06948538362617Carrying CaseBMC Medical Co., Ltd.CC-D12022-08-26
06948538362624Power Cord American StandardBMC Medical Co., Ltd./2022-08-26
06948538362631AC/DC Power AdapterBMC Medical Co., Ltd.AD-YY2022-08-26
06948538362778KnobBMC Medical Co., Ltd.NA2022-09-15
06948538362785Power Cord American StandardBMC Medical Co., Ltd./2022-09-15
06948538362792Filter CapBMC Medical Co., Ltd.FC-D1/FC-D2/FC-D32022-09-15
06948538362853Air FilterBMC Medical Co., Ltd.AF-D12022-09-22
06948538362907Cellular ModuleBMC Medical Co., Ltd.WL-6002022-09-15
06948538364017Water chamberBMC Medical Co., Ltd.YT2A2023-08-04
00606959063266DreamStationRespironics, Inc.DreamStation Auto BiPAP with Humidifier, US2016-08-21
00606959063273DreamStationRespironics, Inc.DreamStation Auto BiPAP w/Humid, w/H Tube, US2016-08-21
00606959424043DreamStationRespironics, Inc.DreamStation Auto BiPAP, USA2016-08-21
00606959424210DreamStationRespironics, Inc.DreamStation BiPAP Pro with Humidifier, US2016-08-21
00606959424234DreamStationRespironics, Inc.DreamStation BiPAP Pro, US2016-08-21
00606959424241DreamStationRespironics, Inc.DreamStation BiPAP Pro w/Humidifier, w/H Tube, US2016-08-21
06948538366363G3 X BPAP 25ABMC Medical Co., Ltd.G47002025-06-09
06948538366387G3 X BPAP SystemBMC Medical Co., Ltd.G48002025-06-09
00619498395309AIRCURVE11 VPAP TXRESMED PTY LTD390242025-01-24
00619498390120AIR 11RESMED PTY LTD390122023-10-31
00619498390137AIR 11RESMED PTY LTD390132023-10-31
00619498390182AIR 11RESMED PTY LTD390182023-10-31
00619498390199AIR 11RESMED PTY LTD390192023-10-31
16948538364014Water chamberBMC Medical Co., Ltd.YT2A2023-08-04
16948538362775KnobBMC Medical Co., Ltd.NA2022-09-15
16948538362782Power Cord American StandardBMC Medical Co., Ltd./2022-09-15
16948538362904Cellular ModuleBMC Medical Co., Ltd.WL-6002022-09-15
16948538362850/BMC Medical Co., Ltd.AF-D12022-09-22
06948538365601Luna® G3 BPAP 25ABMC Medical Co., Ltd.LG37002022-08-29
06948538365632Luna® G3 BPAP 25ABMC Medical Co., Ltd.LG37002022-08-26
06948538365649Luna® G3 BPAP 25ABMC Medical Co., Ltd.LG37002022-08-26
06948538365687Luna® G3 BPAP SystemBMC Medical Co., Ltd.LG3800-25VT2022-08-26
06948538365694Luna® G3 BPAP SystemBMC Medical Co., Ltd.LG3800-25VT2022-08-26
06948538365700Luna® G3 BPAP SystemBMC Medical Co., Ltd.LG3800-25VT2022-08-26
06948538365717Luna® G3 BPAP SystemBMC Medical Co., Ltd.LG3800-30VT2022-08-26
06948538365724Luna® G3 BPAP SystemBMC Medical Co., Ltd.LG3800-30VT2022-08-26
06948538365731Luna® G3 BPAP SystemBMC Medical Co., Ltd.LG3800-30VT2022-08-26
169485383625913BBMC Medical Co., Ltd.WT-D12022-08-26
169485383626073BBMC Medical Co., Ltd.PF-D32022-08-26
169485383626143BBMC Medical Co., Ltd.CC-D12022-08-26
169485383626213BBMC Medical Co., Ltd./2022-08-26
169485383626383BBMC Medical Co., Ltd.AD-YY2022-08-26
00619498282852AIRCURVERESMED PTY LTD282852022-06-10
00619498373840AIRCURVERESMED PTY LTD373842022-06-03
00606959417540DreamStationRespironics, Inc.Micro-Flexible Heated 12mm Tube2021-12-31
00606959063099DreamStation 2Respironics, Inc.DreamStation2 Auto CPAP Advanced with Hu2021-10-26
00619498282241AIRCURVERESMED PTY LTD282242020-07-14
00606959062221DreamStationRespironics, Inc.DreamStation CPAP w/Humidifier/Cellular, AR2021-06-25
00619498360109S9RESMED PTY LTD360102020-07-08
00619498360345VPAPRESMED PTY LTD360342020-07-08
00619498374106AIRCURVERESMED PTY LTD374102020-07-01
00606959044234DreamStationRespironics, Inc.002019-02-22
00619498363773S9RESMED PTY LTD363772019-07-12
00606959000995BiPAPRespironics, Inc.CN657S2019-04-19
00606959001053BiPAPRespironics, Inc.CN657HS2019-04-18
00606959001060BiPAPRespironics, Inc.CN757HS2019-04-18
00606959031357BiPAP System One 60 SeriesRespironics, Inc.BiPAP Pro BiFlex, Sys One 60 Srs, PT2019-04-05
06948538365151RESmart® BPAP SystemBMC Medical Co., Ltd.25A2016-05-19
00619498269235VPAPRESMED PTY LTD269232016-09-13
00619498269242VPAPRESMED PTY LTD269242016-09-13
00619498269259VPAPRESMED PTY LTD269252016-09-13
00619498269266VPAPRESMED PTY LTD269262016-09-13
00619498269310VPAPRESMED PTY LTD269312016-09-13
00619498282104AIRCURVERESMED PTY LTD282102016-09-09
00619498282111AIRCURVERESMED PTY LTD282112016-09-09
00619498282197LUMISRESMED PTY LTD1502016-09-26
00619498360000S9RESMED PTY LTD360002016-09-26
00619498360390VPAPRESMED PTY LTD360392016-12-24
00619498360505S9RESMED PTY LTD360502016-09-26
00619498372157AIRCURVERESMED PTY LTD372152016-09-06
00619498372164AIRCURVERESMED PTY LTD372162016-09-06
00606959023222DreamStationRespironics, Inc.DreamStation Postponement2016-08-21
00606959023284BiPAP System One 60 SeriesRespironics, Inc.BiPAP Pro BiFlex, BR2016-08-20
00606959023291BiPAP System One 60 SeriesRespironics, Inc.BiPAP Auto BiFlex, BR2016-08-20
00606959023529DreamStationRespironics, Inc.DreamStation BiPAP Pro, GB2017-01-03