FDA.reportPublic FDA data

Nebulizing system, non-heated

Definition
An assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.
GUDID devices
1,159
Last updated
2022-05-19 08:16:17

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840117308695Resp-O2 Elite Compressor Nebulizer, Adult/PediatricDynarex Corporation344002022-05-11
00840117308718Resp-O2 Compact Compressor Nebulizer Dynarex Corporation344012022-05-11
00840117308831Resp-O2 Compressor Nebulizer PlusDynarex Corporation344072022-05-11
00840117319455Resp-O2 Compressor NebulizerDynarex Corporation344082022-05-11
05391517936223Aerogen® Solo Nebulizer SystemAEROGEN LIMITED90-2112021-09-10
05391517936292Aerogen® Solo; Aerogen UltraAEROGEN LIMITED90-2142021-09-10
50190752160611AirLife™VYAIRE MEDICAL, INC.52072021-05-07
50190752160628AirLife™VYAIRE MEDICAL, INC.5007P2021-05-07
50190752158489AirLife™VYAIRE MEDICAL, INC.RES441676D2021-04-19
14250892905966VyaireJaeger Medical GmbHV-7075402021-04-15
50190752148367AirLife™VYAIRE MEDICAL, INC.6286-5042021-04-09
50190752114881AirLife™VYAIRE MEDICAL, INC.0024402021-04-02
50190752146882AirLife™VYAIRE MEDICAL, INC.0010112021-04-02
50190752107043AirLife™VYAIRE MEDICAL, INC.0025512021-04-02
50190752148213AirLife™VYAIRE MEDICAL, INC.5900-5042021-04-02
50190752156379AirLife™VYAIRE MEDICAL, INC.0016282021-04-02
50190752156546AirLife™VYAIRE MEDICAL, INC.0021742021-04-02
50190752156553AirLife™VYAIRE MEDICAL, INC.0021752021-04-02
50190752156577AirLife™VYAIRE MEDICAL, INC.0024552021-04-02
50190752156584AirLife™VYAIRE MEDICAL, INC.0025002021-04-02
50190752156591AirLife™VYAIRE MEDICAL, INC.0025032021-04-02
50190752156607AirLife™VYAIRE MEDICAL, INC.0025352021-04-02
50190752156614AirLife™VYAIRE MEDICAL, INC.0025502021-04-02
50190752156638AirLife™VYAIRE MEDICAL, INC.0021732021-04-02
50190752157550AirLife™VYAIRE MEDICAL, INC.002173R2021-04-02
00884389159975MedlineMEDLINE INDUSTRIES, INC.HCS2GO2021-03-31
10080196193103MedlineMEDLINE INDUSTRIES, INC.HCS2GOBATT2021-03-31
40080196418320MedlineMEDLINE INDUSTRIES, INC.HCS4482R2021-03-31
40080196715535MedlineMEDLINE INDUSTRIES, INC.HCS44822021-03-31
40080196715559MedlineMEDLINE INDUSTRIES, INC.HCS44852021-03-31
40080196715566MedlineMEDLINE INDUSTRIES, INC.HCS44862021-03-31
40080196731405MedlineMEDLINE INDUSTRIES, INC.HCS44952021-03-31
40080196731412MedlineMEDLINE INDUSTRIES, INC.HCS44932021-03-31
40080196731429MedlineMEDLINE INDUSTRIES, INC.HCS44922021-03-31
50190752147391AirLife™VYAIRE MEDICAL, INC.0082992021-03-26
05391517936209Aerogen® Solo Continuous Nebulization Tube SetAEROGEN LIMITEDAG-AS3089-US2021-03-23
05391517936216Aerogen® Solo Continuous Nebulization Tube SetAEROGEN LIMITED90-2102021-03-23
50190752156669AirLife™VYAIRE MEDICAL, INC.SPK100128E2021-03-19
05391517936193Aerogen® Solo Nebulizer SystemAEROGEN LIMITEDAG-AS30052021-02-25
00840117308732My Resp-O2 Bear Compressor NebulizerDynarex Corporation344022022-05-11
00840117308763Dynarex My Resp-O2 Doggy Compressor NebulizerDYNAREX CORPORATION344032021-01-19
00840117308787Dynarex My Resp-O2 Piggy Compressor NebulizerDYNAREX CORPORATION344042021-01-19
00840117308794My Resp-O2 Penguin Compressor NebulizerDynarex Corporation344052021-01-19
00810025921040Caring MillCaring MillBEUIH582020-11-02
M368JB01121112John BunnGF HEALTH PRODUCTS, INC.JB0112-1112020-09-25
M6334801500JEDMEDJEDMED INSTRUMENT COMPANY48-01502020-09-01
M6334801510JEDMEDJEDMED INSTRUMENT COMPANY48-01512020-09-01
M6334801630JEDMEDJEDMED INSTRUMENT COMPANY48-01632020-09-01
M6334802860JEDMEDJEDMED INSTRUMENT COMPANY48-02862020-09-01
M368JB01120902JOHN BUNNGF HEALTH PRODUCTS, INC.JB0112-0902020-08-25
24026704717884HUDSON RCITELEFLEX INCORPORATEDIPN9166772020-08-18
24026704717907HUDSON RCITELEFLEX INCORPORATEDIPN9166762020-08-18
24026704717914HUDSON RCITELEFLEX INCORPORATEDIPN9166782020-08-18
24026704670783HUDSON RCITELEFLEX INCORPORATEDIPN9147782020-06-02
24026704670813HUDSON RCITELEFLEX INCORPORATEDIPN9147812020-06-02
10073796800144Omron CompAir Compressor NebulizerOmron Healthcare, Inc.RE-C800KD2020-08-03
00822383004266DriveDrive Devilbiss HealthcareMQ5800-PS2020-07-30
05391517935769Aerogen® Solo; Aerogen UltraAEROGEN LIMITED90-2052020-07-24
05391517935776Aerogen® Solo; Aerogen UltraAEROGEN LIMITED90-1212020-07-24
30641043320000EZflowMERCURY ENTERPRISES, INC.10-320002016-03-07
30641043320017EZflowMERCURY ENTERPRISES, INC.10-320012016-03-07
30641043320031EZflow MAXMERCURY ENTERPRISES, INC.10-320032016-03-09
30641043320048EZflow MAXMERCURY ENTERPRISES, INC.10-320042016-03-09
30641043320093EZflow MAXMERCURY ENTERPRISES, INC.10-320092016-03-09
M6330355460JEDMEDJEDMED INSTRUMENT COMPANY03-55462018-07-13
M6330355470JEDMEDJEDMED INSTRUMENT COMPANY03-55472018-07-13
06973401840015Nebulizer(direct patient interface)Chen Qian Electronic Commerce (Hangzhou) Co., Ltd.WHQ-1902WH(408D)2020-07-16
00822383274485driveDrive Devilbiss HealthcareOM-9002020-07-01
00822383283814driveDrive Devilbiss HealthcareOM-900M2020-07-01
00822383284101driveDrive Devilbiss HealthcareIN6505-L-BLUE2020-07-01
00822383296401driveDrive Devilbiss HealthcareCTOX-MN022020-07-01
00822383984261driveDrive Devilbiss Healthcare18260-PDMASK2020-07-01
05391517934311Aerogen Solo Nebulizer SystemAEROGEN LIMITED60-0742020-06-30
00088530400033DeVilbissDrive Devilbiss Healthcare525PS2017-04-21
05391517935011Aerogen Solo Nebulizer SystemAEROGEN LIMITEDAG-AS5000-PH-US2020-06-09
24026704390414HUDSON RCITELEFLEX INCORPORATEDIPN0444592016-09-16
24026704390650HUDSON RCITELEFLEX INCORPORATEDIPN0444892016-09-16
24026704581645HUDSON RCITELEFLEX INCORPORATEDIPN0445472016-09-16
14719874690042POCKET AIRMICROBASE TECHNOLOGY CORP.MBPN002002020-05-31
14719874690059POCKET AIRMICROBASE TECHNOLOGY CORP.MBPN002012020-05-31