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The OCS™ Heart Leukocyte Depleting Filter is indicated for the reduction of leukocytes from donor blood prior to its introduction into the OCS™ Heart System for the preservation of a donor heart from the same donor.

The OCS™ Heart Leukocyte Depleting Filter is a sterile, single-use filter intended for depletion of leukocytes in donor blood prior to its introduction into the OCS Heart system. The polycarbonate housing is 3.2" high and 3.0" in diameter. It has 1/4" fittings and includes a hydrophobic gas-permeable membrane and vent port to allow air to efficiently vent during priming and use. The leukocyte depleting material is a melt blown polyester media supplied by Pall Biomedical (the same material as is used in the predicate device). It has 6 layers, approximately 5 pleats per inch. It includes a polypropylene extruded diamond mesh that provides support for the polyester filter media. The priming volume is 273.5 mL and the anticipated flow rate (associated with gravity feed from a blood collection bag) is 1.9 L/min. During use, the blood enters through the inlet port, flows through the filter media to the interior of the filter element, and then exits through the outlet port. The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.

The OCS™ Lung Donor Flush Set is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation.

The OCS Lung Donor Flush Set is a sterile single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from donor during the preparation of these organs for transplantation. It is comprised of an already 510(k) cleared cannula (K132811, Sarns Soft-Flow Extended Aorta Cannula) along with the donor flush lines subassembly. The donor flush line assembly consists of silicone tubing, clamps and two spike connectors to enable connection between donor lungs and bags of organ preservation solution. The clamps are used to control the gravity flow of solution from bags to the donor organ. The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.

OCS™ Lung Solution is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

The OCS Lung Solution is a colorless, sterile, pyrogen-free solution for cold flushing, storage and transport of donor lungs for transplantation. The OCS Lung Solution is a colloid-based extracellular low potassium solution for cold flushing and storage of donor lungs for transplantation. The OCS Lung Solution is used to flush and store a lung after removal from the donor. Administration of the solution at the recommended temperature will effectively cool the organ to reduce its metabolic requirements.