33baea94-4de2-45b3-815e-bf78467041d7NewPublished12020-08-312020-08-21In Commercial DistributionM752TMBRF5945PackageHIBCCM752TMBRF594024In Commercial DistributionOUTER BOXM752TMBRF5940PrimaryHIBCCStradis Medical, LLC.TMBRF-594043537671STRADIS MEDICAL LLC1LVAD TRAY ( LEFT VENTRICULAR ASSIST DEVICE TRAY) falsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse1-800-424-8520cs@stradishealthcare.com56732Intracardiac circulatory assist axial-pump catheterA sterile tubular device with a built-in electrically-powered axial flow pump (e.g., a micro motor with an impeller) at the distal end, designed to provide circulatory assistance to the heart by pumping blood during heart failure. It is inserted through the lumen of the aorta and into the left ventricle, surgically or percutaneously via an artery, and connected to an external control unit; it moves blood from the left ventricle to the aorta across the aortic valve. It is typically used emergently post acute myocardial infarction (AMI), electively for high-risk cardiac catheterization, for open chest surgery, and during transport between hospitals. This is a single-use device.falseActiveOEZCardiovascular Procedure Kittruefalse