Device typePhysiologic-monitoring defibrillation system: An 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.
FDA categoryAutomated external defibrillators (non-wearable)
Device ID00883873872048
Catalog number99577-001935
AvailabilityPrescription
LatexNot made with natural rubber latex
MRI safetyMR Unsafe