EMIT Corp has received FDA 510(k) clearance to market the portable fluid-warming HypothermX™ HX100 device. The device is designed to warm intravenous fluids, blood, or blood products infused into a patient to prevent or treat trauma, environmental, procedure related, or induced hypothermia. Heating is accomplished via a flameless hydrocarbon combustion process.
The lightweight HypothermX™ HX100 weighs less than 3 pounds and is suitable for over four hours of continuous use. It is capable of warming up to five liters of saline introduced at 15 degrees C, and 15 units of packed red blood cells introduced at 5 degrees C to 38 degrees C +/- 3 degrees C with an infusion rate between 50 ml/min and 200 ml/min and ambient conditions between 0 degrees C and 40 degrees C.
