FDA.report

Diagnostic spirometer, professional

Definition
An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.
GUDID devices
60
Last updated
2026-04-01 16:43:28

Related Product Codes

CodeDeviceSpecialtyClassDevices
BZGSpirometer, DiagnosticAnesthesiology231
BWFSpirometer, Therapeutic (Incentive)Anesthesiology211
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology29
BYPMouthpiece, BreathingAnesthesiology13
BZCCalculator, Pulmonary Function DataAnesthesiology23
BXPTransducer, Gas FlowAnesthesiology11
BZDVentilator, Non-Continuous (Respirator)Anesthesiology21
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)Anesthesiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
03830059852216MESI mTABLET SPIROMESI d.o.o.MTABSYSSPIRO2026-03-24
04250892908816JaegerJaeger Medical GmbH705560N2025-11-24
04250892908823JaegerJaeger Medical GmbHV-7075252025-11-24
04250892908861JaegerJaeger Medical GmbHV-171470-132025-11-24
14250892907243JaegerJaeger Medical GmbH36-NPROBETU2025-11-24
14250892908509JaegerJaeger Medical GmbH36-TDX10502025-11-24
04057155000955ERT PTeResearchTechnology GmbHERT PT2025-08-11
14250892907748JaegerJaeger Medical GmbH7095542025-07-29
14250892907953JaegerJaeger Medical GmbH36-ASS12702025-07-29
14250892907977JaegerJaeger Medical GmbH36-TDX10512025-07-29
14250892907984JaegerJaeger Medical GmbH36-MFA10502025-07-29
14250892907991JaegerJaeger Medical GmbH36-MFA10102025-07-29
14250892908035JaegerJaeger Medical GmbH36-MLD15872025-07-29
07290019579007STSTECHNOPULM LTD0012025-07-22
14250892908097JaegerJaeger Medical GmbH36-TDX10482025-06-02
14250892908103JaegerJaeger Medical GmbH36-TDX10432025-06-02
050991698301272120 In2itive - BrazilVITALOGRAPH (IRELAND) LIMITED830122025-04-30
00860013746414NxGen Pocket SpirometerSAFEY MEDICAL DEVICES PRIVATE LIMITED1652212025-01-27
30889483570801AirLife™Sunmed Group Holdings, LLC001901A2025-02-11
30889483570825AirLife™Sunmed Group Holdings, LLC001903A2025-02-11
20885632429771HalyardOWENS & MINOR DISTRIBUTION, INC.561782025-02-06
20885632429788HalyardOWENS & MINOR DISTRIBUTION, INC.561792025-02-06
20885632429795HalyardOWENS & MINOR DISTRIBUTION, INC.561802025-02-06
20885632429801HalyardOWENS & MINOR DISTRIBUTION, INC.561812025-02-06
00198715872873NxGen Pocket SpirometerSAFEY MEDICAL DEVICES PRIVATE LIMITED1652212025-01-27
04057155000825SpiroSphereeResearchTechnology GmbHSpiroSphere Main Unit2024-12-03
04057155000580SpiroSphereeResearchTechnology GmbHSpiroSphere ECG2024-07-22
04057155000665SpiroSphereeResearchTechnology GmbHSpiroSphere ECG CT2024-07-22
04057155000689SpiroSphereeResearchTechnology GmbHSpiroSphere Standard ECG2024-07-22
04057155000795iSpiro Ultrasonic SensoreResearchTechnology GmbHiSpiro Ultrasonic Sensor2024-07-22
04057155000818SpiroWayeResearchTechnology GmbHSpiroWay2024-07-22
40612479269918McKessonMCKESSON MEDICAL-SURGICAL INC.16-VOL50002024-05-14
40612479269932McKessonMCKESSON MEDICAL-SURGICAL INC.16-VOL25002024-05-14
40612479269956McKessonMCKESSON MEDICAL-SURGICAL INC.16-DTFLOW2024-05-14
07350002630006Air NextNuvoAir ABNVD-022024-03-20
17350002630027Air NextNuvoAir ABNVD-012024-03-20
04057155000771SpiroSphereeResearchTechnology GmbHSpiroSphere Main Unit2022-12-19
04057155000788SpiroSphereeResearchTechnology GmbHSpiroSphere CT2022-12-19
06934325302294SpirometerFEELLIFE HEALTH INC.Air Smart Extra2023-09-19
00732094325386Welch Allyn, Inc.WELCH ALLYN, INC.9011282023-09-07
00851845007187ComPAS2MORGAN SCIENTIFIC, INC2023.1.02023-08-09
10190752117129AirLifeVYAIRE MEDICAL, INC.001901A2023-08-04
10190752117143AirLifeVYAIRE MEDICAL, INC.001903A2023-08-04
07613365500011SpiroScoutGanshorn Medizin Electronic GmbHF2023-07-03
07613365500035SpiroScout SP PlusGanshorn Medizin Electronic GmbHD2023-07-03
07613365500042SpiroScout SPGanshorn Medizin Electronic GmbHA2023-07-03
07640142190479Spiro-SP TrueFlow SensorNDD Medizintechnik AG2700-1SP2023-06-23
05099169830028IN2ITIVEVITALOGRAPH (IRELAND) LIMITED21202023-05-09
00732094323993Welch Allyn, Inc.WELCH ALLYN, INC.9011282023-04-25
00851845007170ComPAS2MORGAN SCIENTIFIC, INC2022.2.22023-04-12
06934325303741MouthpieceFEELLIFE HEALTH INC.MP12023-02-14
06934325303758Disposable MouthpieceFEELLIFE HEALTH INC.DM12023-02-14
06934325303765Pressure gas blowpipeFEELLIFE HEALTH INC.PB12023-02-14
05099169673021COMPACTVITALOGRAPH (IRELAND) LIMITED66002023-02-10
05099169673038COMPACTVITALOGRAPH (IRELAND) LIMITED66002023-02-10
05099169779570PNEUMOTRACVITALOGRAPH (IRELAND) LIMITED68002022-08-19
05099169779778PNEUMOTRACVITALOGRAPH (IRELAND) LIMITED68002022-08-19
05099169779723PneumotracVITALOGRAPH (IRELAND) LIMITED68002022-07-31
05099169690028AlphaVITALOGRAPH (IRELAND) LIMITED60002022-03-04
00811907031161Pulmonx Chartis Tablet ConsolePULMONX CORPORATIONCHR-CO-3002021-04-20