6a7c7e11-c3a8-4f96-97ab-4f7176997b37UpdatePublished32018-07-062016-04-01In Commercial Distribution00643169463523PrimaryGS1PACEART OPTIMA™ SystemPOS12D14006261481MEDTRONIC, INC.1SW POS12D14 PACEART OPTIMA MKT GLBLfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK11069300044106Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.falseActiveOUGMedical device data systemDXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONEDPSELECTROCARDIOGRAPHKREANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECTStorage Environment HumidityStorage Environment Temperaturefalsefalse