VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)

VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) is an FDA 510(k)-cleared medical device (K913692) manufactured by Bentley Laboratories, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 1991. Regulation: 8.