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The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.

The IBC Vent Valve is a single use, disposable, vacuum relief valve that is intended for use to maintain a low level of vacuum in reservoirs. The valve is closed until the vacuum reaches a pre-determined value in the reservoir and operates best when the pump runs at a very slow rate. The fully assembled IBC Vent Valve is basically identical to the American Omni Vent Valve, which is the predicate device for purposes of this 510(k) submission. The operating principles, performance and indications for use of the two devices are the same. The IBC Vent Valve is manufactured in a Class 100,000 clean room. The device will be packaged and sterilized for single use. Additionally, the IBC Vent Valve will be packaged in bulk form and non-sterile for the Custom Perfusion Pack market. The materials used to manufacture the IBC Vent Valve are non-toxic and meet current ISO biocompatible tripartite standards using the FDA matrix. A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally.