Device typeLung donor-organ perfusion system, non-transport: A mobile, electrically-powered assembly of devices designed to be used for the reconditioning, ex-vivo evaluation and cold preservation of a donated lung prior to transplantation. It typically consists of unit which includes an operator's console, pump mechanism, monitoring sensors, heat exchanger unit and gas exchanger and used together with separately supplied perfusate circuit and lung chamber. Typically, measurements can be made of pulmonary pressure, temperature, and flow, with calculation of pulmonary vascular resistance. It is intended for use in a hospital clean area and not intended for transportation of the donor lung.
FDA categoryNormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Device ID07350069520104
Catalog number19030
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information