FDA.reportPublic FDA data

Therapeutic agent nebulizer, ambulatory

Definition
An electrically-powered, hand-held, portable device intended to be used outside of a clinical setting (e.g., home, outdoors) to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may employ various technologies (ultrasonic, vibrating mesh, or compressor jet type) and consists of a pocket-size unit containing a reservoir to be filled with medication/fluids, and a retractable mouthpiece or attached mask. This device is not a nebulizing chamber.
GUDID devices
43
Last updated
2026-09-29 04:01:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00848530090401Nebulizer MaskSunset Healthcare Solutions, Inc.NEB400-MASKA2024-06-07
00848530092566Nebulizer MaskSunset Healthcare Solutions, Inc.NEB401-MASKA2024-06-07
00023601064011Carex Health BrandsDrive Devilbiss HealthcareFGR40100 00002016-10-07
00023601064035Carex Health BrandsDrive Devilbiss HealthcareFGR40300 00002016-10-07
00023601064042Carex Health BrandsDrive Devilbiss HealthcareFGR40400 00002016-10-07
00023601064066Carex Health BrandsDrive Devilbiss HealthcareFGR40600 00002016-10-07
00023601064080Carex Health BrandsDrive Devilbiss HealthcareFGR40800 00002016-10-07
00023601064127Carex Health BrandsDrive Devilbiss HealthcareFGR41200 00002016-10-07
00023601064158Carex Health BrandsDrive Devilbiss HealthcareFGR41500 00002016-10-07
00023601064165Carex Health BrandsDrive Devilbiss HealthcareFGR41600 00002016-10-07
00073796451004Omron MicroAir Vibrating Mesh NebulizerOmron Healthcare, Inc.NE-U1002018-10-22
00092237603048Roscoe MedicalDrive Devilbiss HealthcareNEB-DINO2016-10-05
00092237603062Roscoe MedicalDrive Devilbiss HealthcareNEB-BUNNY2016-10-05
00092237603116Roscoe MedicalDrive Devilbiss Healthcare500402016-10-05
00092237603178Roscoe MedicalDrive Devilbiss Healthcare500162016-10-11
00092237603185Roscoe MedicalDrive Devilbiss Healthcare500182016-10-07
00092237603307Roscoe MedicalDrive Devilbiss HealthcareNEB-DOG2016-10-05
00092237603314Roscoe MedicalDrive Devilbiss Healthcare32012016-10-07
00092237603352Roscoe MedicalDrive Devilbiss Healthcare500002016-10-05
00092237613924Roscoe MedicalDrive Devilbiss HealthcareNEB-SIERRA2016-10-05
00092237614181Roscoe MedicalDrive Devilbiss HealthcareNEB-ADLTM2016-10-07
00092237614198Roscoe MedicalDrive Devilbiss HealthcareNEB-PEDM2016-10-07
00092237614204Roscoe MedicalDrive Devilbiss HealthcareNEB-ROSKT2016-10-07
00092237619803Roscoe MedicalDrive Devilbiss HealthcareNEB-RITE42018-04-12
00092237621738Roscoe MedicalDrive Devilbiss HealthcareNEB-GO2019-10-01
00810021174006NADongguan SIMZO Electronic Technology Co., Ltd.NBM-3B2025-11-19
00810021174037NADongguan SIMZO Electronic Technology Co., Ltd.NBM-6B2024-01-03
00810021174396BalnoreDongguan SIMZO Electronic Technology Co., Ltd.NBM-4B2025-09-16
00810113578569ViveVIVE HEALTH LLCLVA3077WHT2024-09-04
00810178881710ViveVIVE HEALTH LLCLVA3085DOG2025-04-04
00810178881727ViveVIVE HEALTH LLCLVA3085BEAR2025-04-04
00810178881758ViveVIVE HEALTH LLCLVA3085FLT2026-04-26
00810178887415ViveVIVE HEALTH LLCLVA3085DOGD2026-04-13
00810178887422Vive BreatheVIVE HEALTH LLCLVA3085PEND2026-04-13
06974927380016Mesh NebulizerShenzhen Ivankaca Technology Co.,LtdMY-1252026-05-13
06974927380023Mesh NebulizerShenzhen Ivankaca Technology Co.,LtdMY-1262026-05-13
06974927380092Mesh NebulizerShenzhen Ivankaca Technology Co.,LtdMY-1232026-05-13
00850022483387Dr. Noze Best NebulizerDr. Noze Best, LLCNEBU-0012026-05-26
00850079671010NavägeRhinosystems, Inc.NEB-12026-03-02
00199874417059AirpulseAIRPULSE LTDNBM-6B2026-02-03
00810178886371Vive BreatheVIVE HEALTH LLCLVA3131BRN2026-02-02
00810178884049Vive BreatheVIVE HEALTH LLCLVA3109WHT2026-01-30
00198715785128AirpulseDongguan SIMZO Electronic Technology Co., Ltd.NBM-6B2026-01-02