2 results
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27ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Enforcement
Class III
·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2012
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
FDA Enforcement
Class III
·Terminated·Terumo Cardiovascular Systems Corporation·October 12, 2016