AMSafe(R) Pre-Filled Normal Saline Flush Syringe

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is an FDA 510(k)-cleared medical device (K183473) manufactured by Amsino International, 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 July 11, 2019. Regulation: 8.