The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
A complete portable assembly of noninvasive, non-powered devices intended to be used as part of an extracorporeal bypass system to provide short-term or prolonged (i.e., extra-surgical) mechanical circulatory life support during extracorporeal membrane oxygenation (ECMO) [sometimes referred to as extracorporeal lung support (ECLS)]. It usually includes a centrifugal pump mechanism, defoamer, heat exchanger, membrane oxygenator, and integrated tubing or independent tubing sets. It is intended to be used in conjunction with the capital components (e.g., pump drive unit, gas control unit, heating/cooling unit) and invasive components (e.g., cannulae) of the bypass. This is a single-use device.
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