Details
Device typeCardiopulmonary bypass system heating/cooling unit: A mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. It may be known as a hypothermia/hyperthermia unit because of its ability to regulate body temperature either way.
FDA categoryController, temperature, cardiopulmonary bypass
Device ID04033817900511
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information