FDA.report

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
301
Last updated
2025-08-11 14:17:19

Related Product Codes

CodeDeviceSpecialtyClassDevices
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2286
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology215

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
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
06948538366363/BMC Medical Co., Ltd.G47002025-06-09
06948538366387/BMC 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®BMC Medical Co., Ltd.LG37002022-08-29
06948538365632Luna®BMC Medical Co., Ltd.LG37002022-08-26
06948538365649Luna®BMC Medical Co., Ltd.LG37002022-08-26
06948538365687Luna®BMC Medical Co., Ltd.LG3800-25VT2022-08-26
06948538365694Luna®BMC Medical Co., Ltd.LG3800-25VT2022-08-26
06948538365700Luna®BMC Medical Co., Ltd.LG3800-25VT2022-08-26
06948538365717Luna®BMC Medical Co., Ltd.LG3800-30VT2022-08-26
06948538365724Luna®BMC Medical Co., Ltd.LG3800-30VT2022-08-26
06948538365731Luna®BMC 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 LIMITED360102020-07-08
00619498360345VPAPRESMED LIMITED360342020-07-08
00619498374106AIRCURVERESMED LIMITED374102020-07-01
00606959044234DreamStationRespironics, Inc.002019-02-22
00619498363773S9RESMED LIMITED363772019-07-12
00606959000995BiPAPRespironics, Inc.CN657S2019-04-19
00606959001053BiPAPRespironics, Inc.CN657HS2019-04-18
00606959001060BiPAPRespironics, Inc.CN757HS2019-04-18
00606959031357System One 60 SeriesRespironics, Inc.002019-04-05
06948538365151RESmart®BMC Medical Co., Ltd.25A2016-05-19
00619498269235VPAPRESMED LIMITED269232016-09-13
00619498269242VPAPRESMED LIMITED269242016-09-13
00619498269259VPAPRESMED LIMITED269252016-09-13
00619498269266VPAPRESMED LIMITED269262016-09-13
00619498269310VPAPRESMED LIMITED269312016-09-13
00619498282104AIRCURVERESMED LIMITED282102016-09-09
00619498282111AIRCURVERESMED LIMITED282112016-09-09
00619498282197LUMISRESMED LIMITED1502016-09-26
00619498360000S9RESMED LIMITED360002016-09-26
00619498360390VPAPRESMED LIMITED360392016-12-24
00619498360505S9RESMED LIMITED360502016-09-26
00619498372157AIRCURVERESMED LIMITED372152016-09-06
00619498372164AIRCURVERESMED LIMITED372162016-09-06
00606959023222DreamStationRespironics, Inc.002016-08-21
00606959023284System One 60 SeriesRespironics, Inc.002016-08-20
00606959023291System One 60 SeriesRespironics, Inc.002016-08-20
00606959023529DreamStationRespironics, Inc.002017-01-03
00606959023536DreamStationRespironics, Inc.002017-01-03
00606959023543DreamStationRespironics, Inc.002017-01-03
00606959023550DreamStationRespironics, Inc.002017-01-03
00606959023581DreamStationRespironics, Inc.002016-08-29
00606959023949System One 60 SeriesRespironics, Inc.002016-08-20
00606959023956System One 60 SeriesRespironics, Inc.002016-08-20
00606959023963System One 60 SeriesRespironics, Inc.002016-08-20
00606959023970System One 60 SeriesRespironics, Inc.002016-08-20
00606959023987System One 60 SeriesRespironics, Inc.002016-08-20
00606959023994System One 60 SeriesRespironics, Inc.002016-08-20
00606959024106DreamStationRespironics, Inc.002017-01-03
00606959024281DreamStationRespironics, Inc.002017-01-03
00606959024298DreamStationRespironics, Inc.002017-01-03
00606959024335DreamStationRespironics, Inc.002017-01-03
00606959024342DreamStationRespironics, Inc.002017-01-03