CentriMag Pre-connected Pack Indications for Use [510(k) Clearance; 6-hour use]: The CentriMag Pre-connected Pack is indicated for use with the CentriMag Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
MAT-2215276 v1.0
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