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The Medtronic Bio-Console 560 System with Level Sensing System (LS100) and Level Sensing Tape [LST]) is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours). The Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Level Sensing System includes the Level Sensor (LS100) and the Level Sensor Tape (LST). The Level Sensor System is one of the optional safety systems that can be used with the Medtronic Bio Console 560 Extracorporeal Blood Pumping System and the Medtronic Performer Cardiopulmonary Bypass System. It is designed to be used only with a Medtronic hardshell reservoir.

The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S3 System.

The Stöckert Air Purge Control is a modification of the cleared S3 Level Control/Bubble Detector with the new Air Purge Control module replacing the Bubble Detector. The APC System uses the same Level Control module, Level Control sensor as the predicate device above. The modifications being made to the parent Stöckert S3 Level Control and Bubble Detector consist of three changes: (1) a change to the artwork of the display panel to show "APC" rather than "Bubble Detector," (2) replacement of the "Alarm Clear" key with the "Purge Control" key, and (3) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components.

The LevelSens is an accessory safety device which monitors blood or saline levels in a reservoir and sounds an alarm when the level falls below a predetermined level. It is currently configured for intended use with either Rigid Polycarbonate or Flexible Polyvinyl chloride (PVC) reservoirs.

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