Barrier EasyWarm Active Self-Warming Blanket

Barrier EasyWarm Active Self-Warming Blanket is an FDA 510(k)-cleared medical device (K232508) manufactured by Molnlycke Health Care Us, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2023. Regulation: 8.