FDA.reportPublic FDA data

Diagnostic spirometer

Definition
An electrically-powered device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.
GUDID devices
48
Last updated
2022-02-14 18:02:47

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08908014292003Safey Pocket SpirometerSAFEY MEDICAL DEVICES PRIVATE LIMITED1652212022-02-04
00860008017901CAIRE DiagnosticsCaire Diagnostics Inc.Fenom Pro2022-01-31
00860008017918CAIRE DiagnosticsCaire Diagnostics Inc.Fenom Pro, US2022-01-31
00860008017925CAIRE DiagnosticsCaire Diagnostics Inc.Fenom Pro, EU2022-01-31
00860008017932CAIRE DiagnosticsCaire Diagnostics Inc.Fenom Pro, Demo2022-01-31
00860008017949CAIRE DiagnosticsCaire Diagnostics Inc.Fenom Pro, Australia/New Zealand2022-01-31
00860008017956CAIRE DiagnosticsCaire Diagnostics Inc.Fenom Pro Mouthpieces, Box of 502022-01-31
04250972300172SpiroScout SP plusGanshorn Medizin Electronic GmbHRev.D2021-12-20
04250972300134SpiroScout SPGanshorn Medizin Electronic GmbHA2021-11-30
14250892906543VyaireJaeger Medical GmbH36-MLD16212021-11-16
14250892906550VyaireJaeger Medical GmbH36-TDX10432021-11-16
14250892906567VyaireJaeger Medical GmbH36-TDX10512021-11-15
14250892906574VyaireJaeger Medical GmbH36-TDX10482021-11-15
14250892906635VyaireJaeger Medical GmbH36-TDX10502021-11-15
14250892906680VyaireJaeger Medical GmbH36-MFA10502021-09-24
14250892906697VyaireJaeger Medical GmbH36-MFA10102021-09-24
14250892906703VyaireJaeger Medical GmbH36-ASS12702021-09-24
05099169790490In2itiveVITALOGRAPH (IRELAND) LIMITED21202021-07-19
05099169779020PneumotracVITALOGRAPH (IRELAND) LIMITED68002021-07-16
05099169796744In2itiveVITALOGRAPH (IRELAND) LIMITED21202021-07-16
05099169796799In2itiveVITALOGRAPH (IRELAND) LIMITED21202021-07-16
05099169836037In2itive E-DiaryVITALOGRAPH (IRELAND) LIMITED21202021-07-16
18809276943726Spiro HandleBionet CO,LTDSpiro Handle2021-07-15
04897100310162Andnesfit HealthANDESFIT LIMITEDADF-MSA1002021-05-03
05099169633315MicroVITALOGRAPH (IRELAND) LIMITED63002021-04-16
05099169777576PneumotracVITALOGRAPH (IRELAND) LIMITED68002021-04-16
04057155000719SpiroSphereeResearchTechnology GmbHSpiroSphere Main Unit2021-02-18
04057155000726SpiroSphereeResearchTechnology GmbHSpiroSphere CT2021-02-18
04057155000757SpiroSphereeResearchTechnology GmbHSpiroSphere2021-02-18
04057155000764SpiroSphereeResearchTechnology GmbHSpiroSphere Standard2021-02-18
04057155000566MasterScopeeResearchTechnology GmbHWSSU2021-02-14
04057155000634MasterScopeeResearchTechnology GmbHMasterScope WSSU2021-02-14
04057155000641MasterScopeeResearchTechnology GmbHMasterScope WSSU with ECG2021-02-14
14250892905751VyaireJaeger Medical GmbH36-ASS12702021-01-26
04250892905921JaegerJaeger Medical GmbHV-7075252021-01-22
04057155000610MasterScopeeResearchTechnology GmbHMasterScope CT2020-11-20
04057155000627MasterScopeeResearchTechnology GmbHMasterScope CT with ECG2020-11-20
05099169678019COMPACTVITALOGRAPH (IRELAND) LIMITED66002020-09-30
00841709107924Midmark Digital SpirometerMIDMARK CORPORATION4-000-00272020-06-02
00841709107931Midmark Digital Spirometer w/Calibration SyringeMIDMARK CORPORATION4-000-00282020-06-02
08052990321667MIRMIR MEDICAL INTERNATIONAL RESEARCH SPASpirolab New spirometer Light2018-02-16
08052990321674MIRMIR MEDICAL INTERNATIONAL RESEARCH SPASpirolab New spirometer Light Bluetooth2018-02-16
08809276941480SPM-300Bionet CO,LTD110111-0100002016-09-12
10612479220451McKessonMCKESSON MEDICAL-SURGICAL INC.141-2500-22017-08-04
10863604000312SatelliteJONES MEDICAL INSTRUMENT COMPANY32016-09-24
10884521151673NellcorCovidien LPP-000263-002016-09-24
10884521161832NellcorCovidien LPP-000265-002016-09-24
M776CHRCO100Chartis ConsolePULMONX CORPORATIONG32016-03-25