SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is an FDA 510(k)-cleared medical device (K201936) manufactured by Gilero, LLC. 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 May 5, 2021. Regulation: 8.