Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Circuit, Breathing (W Connector, Adaptor, Y Piece) (CAI) (1) Filter, Bacterial, Breathing-Circuit (CAH) (1)