FDA.reportPublic FDA data

Ambulatory nebulizer, non-heated

Definition
An electrically-powered, hand-held, portable device intended to be used in the home to generate non-heated aerosolized medication/fluids 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
24
Last updated
2025-07-22 16:46:25

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810021174341CadeVitaDongguan SIMZO Electronic Technology Co., Ltd.NBM-8B2025-07-14
00810021174372SRBCareDongguan SIMZO Electronic Technology Co., Ltd.NBM-9B2025-07-14
00810021174389SRBCareDongguan SIMZO Electronic Technology Co., Ltd.NBM-9B2025-07-14
00810021174334AlphamedDongguan SIMZO Electronic Technology Co., Ltd.NBM-7B2025-07-10
00810178881734ViveVIVE HEALTH LLCLVA3085PEN2025-04-04
10810178881717ViveVIVE HEALTH LLCLVA3085DOG2025-04-04
10810178881724ViveVIVE HEALTH LLCLVA3085BEAR2025-04-04
00810021174235RALIMIDongguan SIMZO Electronic Technology Co., Ltd.NBM-112025-02-15
00810021174259AirpulseDongguan SIMZO Electronic Technology Co., Ltd.NBM-6B2025-02-15
00810021174266AnthsaniaDongguan SIMZO Electronic Technology Co., Ltd.NBM-12025-02-15
00810021174273HARTONDongguan SIMZO Electronic Technology Co., Ltd.NBM-6B2025-02-15
10810113578566ViveVIVE HEALTH LLCLVA3077WHT2024-09-04
06976824740184WITCAREMEDShenzhen Witcaremed Medical Technology Co., LtdNBM-3B2024-06-01
00810021174013NADongguan SIMZO Electronic Technology Co., Ltd.NBM-7B2024-01-03
10810021174034NADongguan SIMZO Electronic Technology Co., Ltd.NBM-6B2024-01-03
00023601064172Carex Health BrandsDrive Devilbiss HealthcareFGR41600 00002016-10-11
30023601064012Carex Health BrandsCOMPASS HEALTH BRANDS CORP.FGR40100 00002016-10-07
30023601064036Carex Health BrandsCOMPASS HEALTH BRANDS CORP.FGR40300 00002016-10-07
30023601064043Carex Health BrandsCOMPASS HEALTH BRANDS CORP.FGR40400 00002016-10-07
30023601064067Carex Health BrandsCOMPASS HEALTH BRANDS CORP.FGR40600 00002016-10-07
30023601064081Carex Health BrandsCOMPASS HEALTH BRANDS CORP.FGR40800 00002016-10-07
30023601064128Carex Health BrandsCOMPASS HEALTH BRANDS CORP.FGR41200 00002016-10-07
30023601064159Carex Health BrandsCOMPASS HEALTH BRANDS CORP.FGR41500 00002016-10-07
30023601064166Carex Health BrandsCOMPASS HEALTH BRANDS CORP.FGR41600 00002016-10-07