6fd72a01-ce2d-4e56-b6ba-71e0bfd1bed5UpdatePublished32018-07-062015-06-19In Commercial Distribution04560233593534PrimaryGS1X SERIES610-2441511-36055363428Zoll Medical Corporation1MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, VOICE, NIBP, SPO2, SPCO, SPMET, IBP/TEMP CPR EXPANSION PACK AND ETCO2, FREN JAPANESEfalsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK11243200017882Physiologic-monitoring defibrillation systemAn assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.falseActiveDRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)DQAOximeterMKJAutomated external defibrillators (non-wearable)CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASEDROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)DSKCOMPUTER, BLOOD-PRESSUREDevice Size Text, specify8.9" x 10.4" x 8.75"Storage Environment TemperatureHandling Environment TemperatureStorage Environment Atmospheric PressureStorage Environment Humidityfalsefalse