AMSafe Pre-Filled Normal Saline Flush Syringe

AMSafe Pre-Filled Normal Saline Flush Syringe is an FDA 510(k)-cleared medical device (K213522) 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 March 21, 2022. Regulation: 8.