FDA.reportPublic FDA data

Ultrasonic nebulizing system

Definition
An assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.
GUDID devices
202
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00744229178057eRapidPARI RESPIRATORY EQUIPMENT, INC.178G10302016-09-26
00744229178064eRapidPARI RESPIRATORY EQUIPMENT, INC.178G80302016-09-26
00744229578048MagnairPARI RESPIRATORY EQUIPMENT, INC.578G20002017-12-26
00744229578055MagnairPARI RESPIRATORY EQUIPMENT, INC.578G82002017-12-26
00744229578086MagnairPARI RESPIRATORY EQUIPMENT, INC.578G20012017-12-26
00744229578093MagnairPARI RESPIRATORY EQUIPMENT, INC.578G82012017-12-26
00744229678021AlteraPARI RESPIRATORY EQUIPMENT, INC.678G10022016-09-26
00744229678052AlteraPARI RESPIRATORY EQUIPMENT, INC.678G80002016-09-26
00744229678465LamiraPARI RESPIRATORY EQUIPMENT, INC.678G10402019-01-08
00744229789079Easy CarePARI RESPIRATORY EQUIPMENT, INC.078G63002017-06-30
00744229789109LamiraPARI RESPIRATORY EQUIPMENT, INC.078F30712019-01-08
00744229789116LamiraPARI RESPIRATORY EQUIPMENT, INC.078F26712019-01-08
00845717002820VERIDIANVERIDIAN HEALTHCARE LLC11-5032016-09-26
00845717002837VERIDIANVERIDIAN HEALTHCARE LLC11-5052016-09-26
00845717002844VeridianVERIDIAN HEALTHCARE LLC11-5102016-09-24
00845717002851VERIDIANVERIDIAN HEALTHCARE LLC11-5202016-09-26
00845717003285VeridianVERIDIAN HEALTHCARE LLC11-5122016-09-24
00845717007115VeridianVERIDIAN HEALTHCARE LLC11-5152016-09-24
00852547004054BeurerBEURER NORTH AMERICA, L.P.IH502016-09-24
00856702006013Pocket NebMICROVAPOR DEVICES, LLCMVD-702016-09-24
04719872486022Clinical GuardHEALTH & LIFE CO., LTD.HL1002016-11-03
04719872486039eMistHEALTH & LIFE CO., LTD.EM100A 2017-09-04
04719872486046ALERTCAREHEALTH & LIFE CO., LTD.HL100A2020-06-11
10637320040200VORTRAN-IPPBVORTRAN MEDICAL TECHNOLOGY 1, INCIP-40202016-06-14
10637320040217VORTRAN-IPPB with Water TrapVORTRAN MEDICAL TECHNOLOGY 1, INCIPW-40212016-06-14
10637320040224VORTRAN-IPPB with ManomterVORTRAN MEDICAL TECHNOLOGY 1, INCIPM-40222016-06-14
10637320040309VORTRAN PercussiveNEBVORTRAN MEDICAL TECHNOLOGY 1, INCPNB-40302016-06-14
10637320080305VORTRAN PercussiveNEB 2.0VORTRAN MEDICAL TECHNOLOGY 1, INC80302017-11-02
10637320080404VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer PortVORTRAN MEDICAL TECHNOLOGY 1, INC80402017-11-02
10888277660182MedlineMEDLINE INDUSTRIES, INC.HCSCO2P2021-10-01
10888277698345MedlineMEDLINE INDUSTRIES, INC.CPRM1126FPWT2021-09-21
10888277699236MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.HCSU4483142021-10-01
16970384250814HANGSUNHONSUN (NANTONG) CO.,LTDNB-219C2022-03-31
16970384250821HANGSUNHONSUN (NANTONG) CO.,LTDNB-215C2022-03-31
14719872486043ALERTCAREHEALTH & LIFE CO., LTD.HL100A2020-06-11
06970384250800Take a breathHONSUN (NANTONG) CO.,LTDNB-2222022-03-31
06970384250817HANGSUNHONSUN (NANTONG) CO.,LTDNB-219C2022-03-31
06970384250824HANGSUNHONSUN (NANTONG) CO.,LTDNB-215C2022-03-31
16970384250807Take a breathHONSUN (NANTONG) CO.,LTDNB-2222022-03-31
20888277660189MedlineMEDLINE INDUSTRIES, INC.HCSCO2P2021-10-01
20888277699202MedlineMEDLINE INDUSTRIES, INC.HCS4481VT2021-10-01
20888277699226MedlineMEDLINE INDUSTRIES, INC.HCS4483VT2021-10-01
20888277699233MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.HCSU4483142021-10-01
20888277698342MedlineMEDLINE INDUSTRIES, INC.CPRM1126FPWT2021-09-21
00850022699115GBH-MEDGvm - US IncNB-JLN-MB0052021-09-08
20888277699219MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.HCS4483142021-05-18
00869112000168FLYpCONVEXITY SCIENTIFIC LLC00022021-04-08
00860002180618AireHealth NebulizerAIREHEALTH LLCAH-042021-03-30
00810025921033Caring MillCaring MillBEUIH502020-11-02
04250218591005PolygreenDongguan Polygreen Technology Co., Ltd.KN-91002020-09-10
04250218592101PolygreenDongguan Polygreen Technology Co., Ltd.KN-92102020-09-10
00383730004495TBM MP Gold Chamber Assy TestedRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD1070291T2020-03-24
00383730004501I-neb Clinical Study DiscRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD11041622020-03-24
00383730004518I-neb Generic ClinicalStudy Disc Power10RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD11244982020-03-24
00383730004587I-neb In Vitro Test Disc Power 10RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD10034192020-03-24
00383730004594I-neb In Vitro Test Disc Power 12RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD10037782020-03-24
00383730004600I-neb In Vitro Test Disc Power 6RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD11097972020-03-24
04260217220011USV 2010Amtrion GmbH2010-71-0-000-002020-02-05
04260217220028USV 2010Amtrion GmbH2010-80-0-000-002020-02-05
00860002180601AireHealth NebulizerAIREHEALTH LLCAH032020-01-14
05060488570841Procure NebulizerPROACTIVE MEDICAL PRODUCTS, LLCPMNEBDK2020-01-01
05060488570896Procure NebulizerPROACTIVE MEDICAL PRODUCTS, LLCPMNEBRDK2020-01-01
05060488570902Procure NebulizerPROACTIVE MEDICAL PRODUCTS, LLC002-1027852020-01-01
05060488570919Procure Nebulizer Disposable KitPROACTIVE MEDICAL PRODUCTS, LLC002-1029892020-01-01
30092237621739Roscoe MedicalCOMPASS HEALTH BRANDS CORP.NEB-GO2019-10-01
00383730004181ISG Handset and Mouthpiece Assy RussiaRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002019-06-17
00383730004372ACDC Power Adapter (AUNZ)RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002019-06-17
00383730004389INNOSPIRE GO AUNZRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002019-06-17
00869112000106FLYpCONVEXITY SCIENTIFIC LLC00012019-05-03
42602172200002USV 2010W. Krömker GmbH2010-80-0-000-002016-09-01
42602172200019USV 2010W. Krömker GmbH2010-71-0-000-002016-09-01
14719872486036eMistHEALTH & LIFE CO., LTD.EM100A 2017-09-04
24719872486026Clinical GuardHEALTH & LIFE CO., LTD.HL1002016-11-03
10845717002827VERIDIANVERIDIAN HEALTHCARE LLC11-5032016-09-26
10845717002834VERIDIANVERIDIAN HEALTHCARE LLC11-5052016-09-26
10845717002841VeridianVERIDIAN HEALTHCARE LLC11-5102016-09-24
10845717002858VERIDIANVERIDIAN HEALTHCARE LLC11-5202016-09-26
10845717003282VeridianVERIDIAN HEALTHCARE LLC11-5122016-09-24
00845717007122VeridianVERIDIAN HEALTHCARE LLC11-5162016-09-24
10845717007112VeridianVERIDIAN HEALTHCARE LLC11-5152016-09-24