Device typeIntravascular core temperature regulation system catheter: A flexible tube with an attached membrane (e.g., a balloon) intended to be inserted into the central venous system (CVS) to circulate through the membrane a temperature-controlled fluid (e.g., saline solution), in order to both heat and alternatively cool a patient's blood through the transfer of heat across the membrane. It may have built-in sensors to monitor the patient's body temperature for feedback to a connected control unit. It may be used for body temperature regulation during surgery, intensive care, or for fever management. This is a single-use device.
FDA categorySystem, Hypothermia, Intravenous, Cooling
Device ID00849111075275
Catalog number8700-0783-40
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Safe
Length45 Centimeter
Catheter Gauge9.3 French