ENFLOW IV FLUID WARMER INSULATED STRAP

ENFLOW IV FLUID WARMER INSULATED STRAP is an FDA 510(k)-cleared medical device (K130867) manufactured by Vital Signs, Inc., A GE Healthcare Company. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2013. Regulation: 8.