FDA.reportPublic FDA data

Benchtop nebulizer, non-heated

Definition
An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation.
GUDID devices
234
Last updated
2025-08-20 16:55:28

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06945040110637CONTECContec Medical Systems Co., Ltd.NE-M032025-08-12
05391517937442Aerogen® Solo Nebulizer SystemAEROGEN LIMITEDAG-AS33002025-08-11
14250892907830JaegerJaeger Medical GmbHV-7073072025-07-29
00815991025167BodyMedBOXOUT, LLCBDMNEBCOMREU2025-07-17
24026704661187HUDSON RCITELEFLEX INCORPORATEDIPN0498002025-07-07
05391517936353Aerogen® Solo Nebulizer SystemAEROGEN LIMITEDAG-AS30012025-06-20
05391517938043Aerogen® Solo Nebulizer SystemAEROGEN LIMITEDAG-AS3350-US2025-06-20
05391517938050Aerogen® Solo Nebulizer SystemAEROGEN LIMITEDAG-AS3300-US2025-06-20
05391517938067Aerogen® Solo Nebulizer SystemAEROGEN LIMITEDAG-AS3100-US2025-06-20
05391517938074Aerogen® Solo Nebulizer SystemAEROGEN LIMITEDAG-AS3200-US2025-06-20
20197344137258HUDSON RCIMEDLINE INDUSTRIES, INC.HUD6104TE2025-05-07
05391517938142Aerogen® Solo; Aerogen UltraAEROGEN LIMITEDAG-AS7700-US2025-04-22
20197344137241HUDSON RCIMEDLINE INDUSTRIES, INC.HUD6103TE2025-04-11
30889483570474AirLife™Sunmed Group Holdings, LLC0016082025-03-27
30889483569164AirLife™Sunmed Group Holdings, LLC0010102025-03-18
30889483569188AirLife™Sunmed Group Holdings, LLC0010122025-03-18
30889483569195AirLife™Sunmed Group Holdings, LLC0010132025-03-18
30889483570931AirLife™Sunmed Group Holdings, LLC0020582025-03-18
30889483570955AirLife™Sunmed Group Holdings, LLC0020612025-03-18
05391517937725Aerogen® Solo Nebulization SystemAEROGEN LIMITEDAG-PX1000-US2025-03-12
05391517937732Aerogen® USB Controller SystemAEROGEN LIMITEDAG-UC1000-US2025-03-12
06956937002850HomedShenzhen Homed Medical Device Co., Ltd.JLN-2322AS2025-03-10
30889483598508AirLife™Sunmed Group Holdings, LLCCC102025-03-07
30889483598546AirLife™Sunmed Group Holdings, LLCCK00052025-03-07
30889483570382AirLife™Sunmed Group Holdings, LLC0015052025-02-20
30889483570481AirLife™Sunmed Group Holdings, LLC0016182025-02-20
30889483570498AirLife™Sunmed Group Holdings, LLC0016282025-02-20
30889483570894AirLife™Sunmed Group Holdings, LLC0020022025-02-20
30889483570948AirLife™Sunmed Group Holdings, LLC0020602025-02-20
30889483570993AirLife™Sunmed Group Holdings, LLC0021732025-02-20
30889483571044AirLife™Sunmed Group Holdings, LLC0024312025-02-20
30889483571051AirLife™Sunmed Group Holdings, LLC0024322025-02-20
30889483571068AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m)Sunmed Group Holdings, LLC0024332025-02-20
30889483571075AirLife™Sunmed Group Holdings, LLC0024342025-02-20
30889483571082AirLife™Sunmed Group Holdings, LLC0024352025-02-20
30889483571099AirLife™Sunmed Group Holdings, LLC0024372025-02-20
30889483571105AirLife™Sunmed Group Holdings, LLC0024382025-02-20
30889483571150AirLife™Sunmed Group Holdings, LLC0024442025-02-20
30889483571174AirLife™Sunmed Group Holdings, LLC0024462025-02-20
30889483571198AirLife™Sunmed Group Holdings, LLC0024502025-02-20
30889483571242AirLife™Sunmed Group Holdings, LLC0025012025-02-20
30889483571259AirLife™Sunmed Group Holdings, LLC0025022025-02-20
30889483571273AirLife™Sunmed Group Holdings, LLC0025302025-02-20
30889483571280AirLife™Sunmed Group Holdings, LLC0025332025-02-20
30889483571297AirLife™Sunmed Group Holdings, LLC0025342025-02-20
30889483571938AirLife™Sunmed Group Holdings, LLC0082992025-02-20
30889483569171AirLife™Sunmed Group Holdings, LLC0010112025-02-19
30889483570368AirLife™Sunmed Group Holdings, LLC0015032025-02-19
30889483571235AirLife™Sunmed Group Holdings, LLC0025002025-02-19
30889483571266AirLife™Sunmed Group Holdings, LLC0025032025-02-19
30889483571303AirLife™Sunmed Group Holdings, LLC0025352025-02-19
30889483571310AirLife™Sunmed Group Holdings, LLC0025502025-02-19
30889483571327AirLife™Sunmed Group Holdings, LLC0025512025-02-19
10889483585535AirLife™AIRLIFE52072025-02-18
30889483599710AirLife™Sunmed Group Holdings, LLCFN24332025-02-17
30889483599727AirLife™Sunmed Group Holdings, LLCFN24342025-02-17
30889483599741AirLife™Sunmed Group Holdings, LLCFN24392025-02-17
30889483599758AirLife™Sunmed Group Holdings, LLCFN24442025-02-17
30889483599765AirLife™Sunmed Group Holdings, LLCFN24452025-02-17
30889483584587AirLife™Sunmed Group Holdings, LLC5007P2025-02-12
30889483599734AirLife™Sunmed Group Holdings, LLCFN24382025-02-11
30889483599772AirLife™Sunmed Group Holdings, LLCFN24462025-02-05
10197344037155HUDSON RCIMEDLINE INDUSTRIES, INC.HUD6114T2024-11-22
10197344037162HUDSON RCIMEDLINE INDUSTRIES, INC.HUD6113T2024-11-22
10197344037179HUDSON RCIMEDLINE INDUSTRIES, INC.HUD6112T2024-11-22
05391517937466Aerogen® Solo Nebulizer SystemAEROGEN LIMITEDAG-AS3300-US2024-10-28
10197344037186HUDSON RCIMEDLINE INDUSTRIES, INC.HUD6111T2024-10-28
50628725098208VixOne™ Nebulizer Kit Canadian Hospital Specialties LimitedR-6405S2024-08-20
04719873130191Aerogen®GoHCMED INNOVATIONS CO., LTD.HCM-86C2024-08-20
10848530087521Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.NEB200CORD2024-08-07
10848530087538Nebulizer AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.NEB200MP2024-08-07
10848530099890Nebulizer AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.NEB402-CUP2024-08-07
10848530099920Nebulizer AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.NEB402-MP2024-08-07
10848530090347Nebulizer KitSUNSET HEALTHCARE SOLUTIONS, INC.RES095MP2024-08-01
10848530087507Nebulizer and CompressorSUNSET HEALTHCARE SOLUTIONS, INC.NEB2002024-07-30
10848530090354Nebulizer KitSUNSET HEALTHCARE SOLUTIONS, INC.RES0952024-07-31
10848530093881Nebulizer and CompressorSUNSET HEALTHCARE SOLUTIONS, INC.NEB300BEARNC2024-07-30
10848530095069Nebulizer and CompressorSUNSET HEALTHCARE SOLUTIONS, INC.NEB100NC2024-07-30
10848530095076Nebulizer and CompressorSUNSET HEALTHCARE SOLUTIONS, INC.NEB300FISHNC2024-07-30
10848530098565Nebulizer KitSUNSET HEALTHCARE SOLUTIONS, INC.RES195-102024-07-19