c1ef65d4-6c9f-416c-9a4c-85bce464b921UpdatePublished62022-03-082016-09-212020-02-27Not in Commercial DistributionB279SIB405050PrimaryHIBCCAstra Spirometer TouchSIB405-050037690120S D I DIAGNOSTICS INC1Spirometer falsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK06157100013680Diagnostic spirometer, professionalAn 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.falseActiveBZGSpirometer, Diagnosticfalsefalse