DRAIN/PRIMING/RECIRCULATION BAG

DRAIN/PRIMING/RECIRCULATION BAG is an FDA 510(k)-cleared medical device (K913361) manufactured by Haemotronic, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 1992. Regulation: 8.