Genesis Low Temperature Reusable Rigid Container System

Genesis Low Temperature Reusable Rigid Container System is an FDA 510(k)-cleared medical device (K153554) manufactured by Carefusion 2200, Inc.. 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 March 20, 2016. Regulation: 8.