FDA.reportPublic FDA data

Benchtop nebulizer, heated

Definition
An assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).
GUDID devices
23
Last updated
2023-02-24 09:28:04

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
54026704733632HUDSON RCITELEFLEX INCORPORATEDIPN9248492023-02-16
05060488573590Protekt NebulizerPROACTIVE MEDICAL PRODUCTS, LLCPMNEBRDK-BF2022-11-18
05060488573613Protekt NebulizerPROACTIVE MEDICAL PRODUCTS, LLCPMNEBRDK-OT2022-11-18
05060488573637Protekt NebulizerPROACTIVE MEDICAL PRODUCTS, LLCPMNEBRDK-PP2022-11-18
14026704597304HUDSON RCITELEFLEX INCORPORATEDIPN0406502016-09-16
14026704597311HUDSON RCITELEFLEX INCORPORATEDIPN0406552016-09-16
50885403010994AirLifeCarefusion Corporation0025012016-09-01
50885403039117AirLifeCarefusion Corporation0024322016-09-01
50885403039124AirLifeCarefusion Corporation0024372016-09-01
50885403039131AirLifeCarefusion Corporation0024392016-09-01
50885403039148AirLifeCarefusion Corporation0024402016-09-01
50885403039155AirLifeCarefusion Corporation0024422016-09-01
50885403039162AirLifeCarefusion Corporation0024452016-09-01
50885403039179AirLifeCarefusion Corporation0024472016-09-01
50885403039209AirLifeCarefusion Corporation0024552016-09-01
50885403039216AirLifeCarefusion Corporation0024582016-09-01
50885403039223AirLifeCarefusion Corporation0024602016-09-01
50885403039230AirLifeCarefusion Corporation0025002016-09-01
50885403039254AirLifeCarefusion Corporation0025032016-09-01
50885403039285AirLifeCarefusion Corporation0025352016-09-01
50885403039292AirLifeCarefusion Corporation0025502016-09-01
50885403039308AirLifeCarefusion Corporation0025512016-09-01
50885403039803AirLifeCarefusion Corporation7331-HS52016-09-01