b95fff3c-3a9c-4a01-bd75-1496f6aa37dfUpdatePublished32018-07-062015-03-20In Commercial Distribution05414734301619PrimaryGS1Inquiryâ„¢IBI-80468IBI-80468926346966IRVINE BIOMEDICAL, INC.1falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(855)478-5833customerservice@sjm.comK94633300046355Cardiac mapping catheter, percutaneous, single-useA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.falseActiveDRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGCatheter GaugeSpecial Storage Condition, SpecifyStore in a cool, dry location.truefalse