Title 21

SECTION 870.4240

870.4240 Cardiopulmonary bypass heat exchanger.

§ 870.4240 Cardiopulmonary bypass heat exchanger.

(a) Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

(b) Classification. Class II (performance standards).

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