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Sorin Group Italia S.R.L.
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BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG is an FDA 510(k)-cleared medical device (K112771) manufactured by Sorin Group Italia S.R.L.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 13, 2011. Regulation: 8.