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
997
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00619498390007AIR 11RESMED PTY LTD390002021-03-31
00850003157009DreamportsBLEEP, LLC1003792019-03-27
00850003157016DreamwayBLEEP, LLC1003812019-03-27
00850003157023DreamprepBLEEP, LLC1004332019-03-27
00850003157061HMEBLEEP, LLC1005922022-08-23
00850003157085Vent filter 24 packBLEEP, LLC1005952022-08-23
00850003157092Vent diffuser kit 24 packBLEEP, LLC1006052022-08-23
00850003157115Bleep HalosBLEEP, LLC1005902022-08-23
00850003157122Eclipse Starter KitBLEEP, LLC1005892022-08-23
00850003157177Eclipse Vent Diffuser KitBLEEP, LLC1006612022-10-11
00850003157184Eclipse Vent Filter Replacement PackBLEEP, LLC1006622022-10-11
00850003157214Eclipse Vent FilterBLEEP, LLC100671 2023-08-21
00884838075399WhisperPak, Pre-Hosp, 7.5cmH2O CPAP, 10Respironics Novametrix, LLC002017-09-01
00884838075405WhisperPak, Pre-Hosp 5cmH2O CPAP Case 10Respironics Novametrix, LLC002017-09-01
00884838075412WhisperPak, 5.0cm CPAP, Bari U Hosp, 10Respironics Novametrix, LLC002017-09-01
00884838075429WhisperPak 10.0cmH2O CPAP Bari U Hosp 10Respironics Novametrix, LLC002017-09-01
00884838075436WhisperPak, 7.5cmH2O CPAP Bari U Hosp 10Respironics Novametrix, LLC002017-09-01
00884838075443WhisperPak, M520 V5 H033 T956, Case 10Respironics Novametrix, LLC002017-09-01
00884838075450WhisperPak, M520 V7 H033 T956, Case 10Respironics Novametrix, LLC002017-09-01
00884838075467WhisperPak, M520 V10 H033 T956, Case 10Respironics Novametrix, LLC002017-09-01
00884838075474WhisperPak, M520 V7 H113 T2m, Case 10Respironics Novametrix, LLC002017-09-01
00884838075498WhisperPak 7.5cmH2O CPAP Ribbed, Med, 10Respironics Novametrix, LLC002017-09-01
00884838075504WhisperPak 5.0cmH2O CPAP, Normed Case 10Respironics Novametrix, LLC002017-09-01
00884838075542WhisperPak, M520 V5 H113 T2m, Case 10Respironics Novametrix, LLC002017-09-01
00884838075559WhisperPak, M520 H113 T2m, Case 10Respironics Novametrix, LLC002017-09-01
00884838075566WhisperPak, M520 V10 H113 T2m, Case 10Respironics Novametrix, LLC002017-09-01
00884838075580WhisperPak, Face Mask, Case 10Respironics Novametrix, LLC002017-09-01
00884838075597WhisperPak 5.0cmH2O CPAP Gamida, Case 10Respironics Novametrix, LLC002017-09-01
00884838075603WhisperPak 7.5cmH2O CPAP Gamida, Case 10Respironics Novametrix, LLC002017-09-01
00884838075634WhisperPak 5.0cmH2O - 22mm CPAP, Case 10Respironics Novametrix, LLC002017-09-01
00884838075641WhisperPak, 7.5cmH2O - 22mm CPAP, Case 10Respironics Novametrix, LLC002017-09-01
00884838075658WhisperPak, 10cmH2O - 22mm CPAP, Case 10Respironics Novametrix, LLC002017-09-01
00884838082533WhisperPak, M572 V7 T956 C142 C955, 10Respironics Novametrix, LLC002017-09-05
00884838082540WhisperPak, M572 V10 T956 C142 C955 Case 10Respironics Novametrix, LLC002017-09-01
00884838082557WhisperPak, PerformaTrak, MEDRespironics Novametrix, LLC002017-09-01
00884838082564WhisperPak, M691 V10 T2m C500, Case 10Respironics Novametrix, LLC002017-09-01
00884838082571WhisperPak, M572 V10 T987 C142 C955, 10Respironics Novametrix, LLC002017-08-29
00885304020868DeVilbissDEVILBISS HEALTHCARE LLCDV63E2016-09-23
00885304022060DeVilbissDEVILBISS HEALTHCARE LLCDV51D-LA2017-08-07
00885304022077DeVilbissDEVILBISS HEALTHCARE LLCDV53D-LA2017-08-08
00885304022084DeVilbissDEVILBISS HEALTHCARE LLCDV54D-LA2017-08-08
00885304022091DeVilbissDEVILBISS HEALTHCARE LLCDV55D-LA2017-08-08
00885304022107DeVilbissDEVILBISS HEALTHCARE LLCDV57D-LA2017-08-08
00885304022114DeVilbissDEVILBISS HEALTHCARE LLCDV51D-HH-LA2017-08-07
00885304022121DeVilbissDEVILBISS HEALTHCARE LLCDV53D-HH-LA2017-08-08
00885304022138DeVilbissDEVILBISS HEALTHCARE LLCDV54D-HH-LA2017-08-08
00885304022145DeVilbissDEVILBISS HEALTHCARE LLCDV55D-HH-LA2017-08-08
00885304022152DeVilbissDEVILBISS HEALTHCARE LLCDV57D-HH-LA2017-08-08
03700659400257GoodKnightSEFAMGoodKnight 420G2016-10-10
03700659400264GoodKnightSEFAMGoodKnight 420S2016-10-10
03700659400271GoodKnightSEFAMGoodKnight 420E2016-10-10
04713025000028APEXWellell Inc.9S-005500, 9S-0065002016-09-23
04713025000042APEXWellell Inc.9S-005530, 9S-0065002016-09-23
04713025000059APEXWellell Inc.9S-0055802016-09-23
04713025000066APEXWellell Inc.9S-005580, 9S-0065002016-09-23
04713025000073APEXWellell Inc.9S-0057202016-09-23
04713025000080APEXWellell Inc.9S-005720, 9S-0065002016-09-23
04713025000103APEXWellell Inc.9S-0072012016-09-23
04713025000110APEXWellell Inc.9S-0071012016-09-23
04713025000127APEXWellell Inc.9S-0070012016-09-23
04713025000158APEXWellell Inc.9S-0070002016-09-23
06948538362648AC/DC Power AdapterBMC Medical Co., Ltd.AD-NJ2022-08-29
06948538362655Carrying CaseBMC Medical Co., Ltd.CC-C1-3BM2022-08-29
06948538362662AC/DC Power AdapterBMC Medical Co., Ltd.AD-B22022-08-29
06948538362679Water chamberBMC Medical Co., Ltd.WT-B12023-08-21
06948538362754Filter CapBMC Medical Co., Ltd.FC-C12022-09-22
06948538362761KnobBMC Medical Co., Ltd.NA2022-09-15
06948538362846Air FilterBMC Medical Co., Ltd.AF-B22022-09-22
06948538362877Carrying CaseBMC Medical Co., Ltd./2022-09-15
06948538362884Cellular ModuleBMC Medical Co., Ltd.WL-3002022-09-15
06948538362891WiFi KitBMC Medical Co., Ltd.WL-1002022-09-15
06948538362914WiFi KitBMC Medical Co., Ltd.WL-5002022-09-22
06948538362990Carrying CaseBMC Medical Co., Ltd.CC-E12023-03-03
06948538363379Filter CapBMC Medical Co., Ltd.FC-E12023-03-03
06948538363386AC/DC Power AdapterBMC Medical Co., Ltd.AD-E32023-03-03
06948538363393Display ShellBMC Medical Co., Ltd./2023-03-03
06948538364284Blank SD Card for Pap DevicesBMC Medical Co., Ltd.P600-16G2023-04-07
07321822050008Breas iSleep 20 SystemBreas Medical ABUS2016-09-20
07321822060007Breas iSleep 20+ systemBreas Medical ABUS2016-09-20
07321822070006Breas iSleep 20i systemBreas Medical ABUS2016-09-20