FDA.reportPublic FDA data

Heated respiratory humidifier

Definition
A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.
GUDID devices
564
Last updated
2026-10-04 01:13:28

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10197344010813HUDSON RCIMEDLINE INDUSTRIES, INC.HUD395992026-09-21
00848530070670Heated CPAP Tube for DreamStation Series and PR System OneSunset Healthcare Solutions, Inc.TUB006SSRP2024-03-05
00848530090609Heated CPAP TubeSunset Healthcare Solutions, Inc.TUB06HPR2021-10-14
00848530102753Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.TUB06HPR-E2024-02-20
00848530104153Passive Heated Breathing Circuit KitSunset Healthcare Solutions, Inc.VC1114-KIT2024-05-30
06971156891849EquateWAL-MART STORES, INC.4L2026-07-31
00885304008798DeVilbissDEVILBISS HEALTHCARE LLCDV57D-HH-S-HT2020-04-03
00612223001322CURAPLEXPEGASUS RESEARCH CORPORATION301-0131EA2021-09-15
00612223001346CURAPLEXPEGASUS RESEARCH CORPORATION301-0133EA2021-09-15
00612223013202CURAPLEXPEGASUS RESEARCH CORPORATION301-0133EA2021-09-15
00612223035013MISTICPEGASUS RESEARCH CORPORATIONP35002016-09-27
00612223701017PEGASUSPEGASUS RESEARCH CORPORATIONP701002021-09-17
00619498374717HumidAirRESMED PTY LTD374712026-02-09
00619498374793HUMID AIRRESMED PTY LTD374792018-09-21
00709078002274High Flow Transport CircuitWESTMED, INC.94052016-12-30
00709078002281NeoPodWESTMED, INC.94032017-04-11
00709078002298NeoPodWESTMED, INC.94022016-12-30
00709078002311NeoPodWESTMED, INC.94092017-04-17
00709078005022"Neo-Pod™ ""T"""WESTMED, INC.9403U2017-10-20
00709078008184Neo-Pod T CircuitWESTMED, INC.93992019-10-31
00709078012174Controllers/AccessoriesWESTMED, INC.43502020-09-30
00840106905454O2asis HumidifierPERMA PURE LLCO2asis Water Pump2023-06-07
00840106905478O2asis HumidifierPERMA PURE LLCBase Unit2023-06-07
00840106905645O2asis HumidifierPERMA PURE LLCPediatric Cannula2023-06-07
03700659400301GoodKnightSEFAMGoodKnight H2O2016-10-10
04026704396122HUDSON RCITELEFLEX INCORPORATEDIPN0442682016-09-16
04026704396146HUDSON RCITELEFLEX INCORPORATEDIPN0442692016-09-16
04026704396153HUDSON RCITELEFLEX INCORPORATEDIPN0442702016-09-16
04026704396160HUDSON RCITELEFLEX INCORPORATEDIPN0442712016-09-16
04026704396238HUDSON RCITELEFLEX INCORPORATEDIPN0442912016-09-16
04026704396245HUDSON RCITELEFLEX INCORPORATEDIPN0442922016-09-16
04026704396290HUDSON RCITELEFLEX INCORPORATEDIPN0442952016-09-16
04026704396313HUDSON RCITELEFLEX INCORPORATEDIPN0442972016-09-16
04026704396337HUDSON RCITELEFLEX INCORPORATEDIPN0442992016-09-16
04026704396344HUDSON RCITELEFLEX INCORPORATEDIPN0443012016-09-16
04026704396368HUDSON RCITELEFLEX INCORPORATEDIPN0443032016-09-16
04026704396375HUDSON RCITELEFLEX INCORPORATEDIPN0443042016-09-16
04026704396382HUDSON RCITELEFLEX INCORPORATEDIPN0443052016-09-16
04026704396399HUDSON RCITELEFLEX INCORPORATEDIPN0443112016-09-16
04026704396702HUDSON RCITELEFLEX INCORPORATEDIPN0445992016-09-16
04026704559336HUDSON RCITELEFLEX INCORPORATEDIPN0442802016-09-16
04026704582068HUDSON RCITELEFLEX INCORPORATEDIPN0442812016-09-16
04026704589890HUDSON RCITELEFLEX INCORPORATEDIPN0442932016-09-16
04026704589906HUDSON RCITELEFLEX INCORPORATEDIPN0442962016-09-16
04026704589913HUDSON RCITELEFLEX INCORPORATEDIPN0443002016-09-16
04026704597604HUDSON RCITELEFLEX INCORPORATEDIPN0442822016-09-16
04026704597673HUDSON RCITELEFLEX INCORPORATEDIPN0442942016-09-16
04026704597727HUDSON RCITELEFLEX INCORPORATEDIPN0442982016-09-16
04026704597758HUDSON RCITELEFLEX INCORPORATEDIPN0443062016-09-16
04026704597765HUDSON RCITELEFLEX INCORPORATEDIPN0443072016-09-16
04026704597789HUDSON RCITELEFLEX INCORPORATEDIPN0443202016-09-16
04026704597796HUDSON RCITELEFLEX INCORPORATEDIPN0443232016-09-16
04026704597833HUDSON RCITELEFLEX INCORPORATEDIPN0444922016-09-16
04710810117121galemedGALEMED CORPORATION34312015-10-15
04713025000097APEXWellell Inc.9S-0065002016-09-23
04719894380933VADIVADI MEDICAL TECHNOLOGY CO., LTD.G-3140032023-10-16
05030267095810N/AIntersurgical Incorporated23100302016-09-24
05030267095834N/AIntersurgical Incorporated23200302016-09-24
05030267095858N/AIntersurgical Incorporated23300302016-09-24
06948538362013RESmart® Integrated Heated Humidifier for CPAPBMC Medical Co., Ltd.BMC-502016-05-19
06948538362020RESmart® Integrated Heated Humidifier for Auto CPAPBMC Medical Co., Ltd.BMC-502016-05-19
06948538362037RESmart® Integrated Heated Humidifier for BPAP 25ABMC Medical Co., Ltd.BMC-502016-05-19
06948538362044Luna®BMC Medical Co., Ltd.H602016-05-19
07321820035304HA01Breas Medical ABUS2016-09-20
08717146000420Medisize®Medisize B.V.360 000 0002016-10-11
08717146061025Medisize®Medisize B.V.358 933 4002016-10-11
09420012403209Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900MR8182016-09-08
09420012416810Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHC550JHU2016-09-08
09420012427847Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900ICON2002016-09-08
09420012442314Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900SPS1002019-05-12
10197344009725HUDSON RCIMEDLINE INDUSTRIES, INC.HUD382102026-01-26
10197344010936HUDSON RCIMEDLINE INDUSTRIES, INC.HUD872DTPCS2023-12-27
10351688517029PortexICU MEDICAL, INC.11312016-10-11
10351688517036PortexICU MEDICAL, INC.11402016-10-11
10351688517043PortexICU MEDICAL, INC.11412016-10-11
10351688517050MedexICU MEDICAL, INC.1141202016-10-11
10801902124644HUDSON RCITELEFLEX INCORPORATEDIPN0443092016-09-16
10801902124651HUDSON RCITELEFLEX INCORPORATEDIPN0443082016-09-16
10801902124668HUDSON RCITELEFLEX INCORPORATEDIPN0443102016-09-16
10885403296574AirLifeCarefusion Corporation9250EU2016-09-21