be6562d6-ad1f-4424-91e5-b8720075f6a1UpdatePublished22020-09-072018-06-01In Commercial DistributionB00938535PrimaryHIBCCB00938537PackageHIBCCB009385351In Commercial DistributionCardboard BoxOCS Lung System22002200084445043TRANSMEDICS, INC.1OCS Lung Perfusion SetfalsefalsefalsefalsefalsetruefalsetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse62831Lung donor-organ preservation/transport perfusion setA collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated lung(s) during its preservation, evaluation, and transport in a lung donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, ventilator, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the lung(s), and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.falseActiveQBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To TransplantationHeightWidthLengthHandling Environment TemperatureHandling Environment HumidityHandling Environment Atmospheric Pressuretruefalse