THERMACYL BLOOD/FLUID WARMER

THERMACYL BLOOD/FLUID WARMER is an FDA 510(k)-cleared medical device (K953741) manufactured by Baxter Healthcare Corp. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 1996. Regulation: 8.