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EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is intended for topical cooling of in situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient. EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport. It is also indicated for use during open surgical procedures such as cardiovascular, abdominal, and transplant surgeries. Organ Recovery Prior to organ recovery, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery. During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ). Organ Storage/Transport For organ storage/transport, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, the slushed solution may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions. Surgical Procedure During surgical procedures, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is delivered to assist in creating hypothermia by topically cooling external surfaces of organs. During the procedure, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional slushed solution may be delivered per established surgical team procedures.

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is a clear, colorless 0.9% Sodium Chloride solution for preparation of slushed solution to provide hypothermia during the recovery, storage, and transport of donor organs for transplantation and to induce regional hypothermia in certain surgical procedures such as open heart and kidney procedures by direct application of slushed solution. The solution is sterile, non-pyrogenic, isotonic and is contained in a 2L sterile, flexible, non- PVC bag.

Belzer UW® Cold Storage Solution (BTLBUW-001) is indicated for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. Belzer UW® Cold Storage Solution (BTLBUW-001) is not indicated for continuous machine perfusion.

Belzer UW® Cold Storage Solution (BTLBUW-001) is a clear to light yellow, sterile, nonpyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolarity of 320 mosmol/kg, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C. The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols. The Belzer UW® Cold Storage Solution (BTLBUW-001) is supplied in non-PVC bags: 500 mL bags, shelf carton of 6; 1000 mL in 1-liter bags, shelf carton of 10; and 2000 mL in 2-liter bags, shelf carton of 5. The solution is sterile and is intended for one single use. The solution should be stored indoors at temperatures controlled between 2° and 25°C (36° and 77°F) until use. Excessive heat and freezing should be avoided. Belzer UW® Cold Storage Solution (BTLBUW-001) should not be used if discolored or if obvious particulate matter, precipitates, or contamination are evident in the solution.

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is a clear to straw-colored, sterile, non-pyrogenic solution for the in-vitro flushing and continuous perfusion of explanted abdominal organs. The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) has the same composition and indication for use as MaPerSol® Organ Preservation Solution. The solution is consistent with an extracellular solution, based on its sodium/potassium ratio and has a calculated potassium concentration of 25 mEq/L, a sodium concentration of 100 mEq/L, an osmolarity of 300 mosmol/kg, and a pH of approximately 7.4 at 20°C. The Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is supplied in single use 1000mL solution bags, made from flexible PVC free material (e.g., laminated EVA film) with at least two integrated ports including ports for delivery and component addition. Each individual bag is enclosed in a protective outer overwrap bag. The solution is sterile and is intended for one single use.

The OrganProtex™ HTK Solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs.

OrganProtex™ HTK Solution is a clear, colorless to pale yellow colored solution, sterile, nonpyrogenic electrolyte and amino acid aqueous solution for organ perfusion and preservation. OrganProtex™ HTK Solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs. Histidine-tryptophan-ketoglutarate or HTK solution is a high-flow, low-potassium preservation solution used for organ transplantation. The solution was initially developed by Hans-Jurgen Bretschneider. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine hydrochloride, so as to prolong the period during which the organs will tolerate interruption of oxygenated blood. The composition of HTK is similar to that of extracellular fluid. All of the components of HTK, with the exception of mannitol, occur naturally in the body. The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.

Cannula for Organ Perfusion is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor organs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation. This device is indicated for use with gravity flow; no testing has been provided for use with pump systems, such as mechanical perfusion devices.

The Cannula for Organ Perfusion is a device designed and intended as a component to an organ perfusion and transport system / organ preservation solution, used in an organ transplantation procedure. The device is a cannula (available in several different sizes) intended for flushing and replacement of residual blood in donor organs with organ preservation solution during the preparation processes of these organs for transplantation. The cannulas are single use, sterile, non-toxic and nonpyrogenic devices. As a component to an organ perfusion and transport system / organ preservation solution, the Cannula for Organ Perfusion is also a Class II medical device, subject to Product Code KDN and MSB, 21 CFR 876.5880: "This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set." (21 CFR 876.5880(a)). The Cannulas come in multiple sizes, according to the French catheter scale, including 8F, 10F, 12F, 16F (adjustable to 18F with a slidable ring), 20F (adjustable to 28F with a slidable ring), 25F (adjustable to 34F with a slidable ring). In addition, there is a configuration of the cannula that is intended for "back table" procedures, which is available in a 16F size.

EasiSlush™ slushed solution is intended for topical cooling of in-situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient. EasiSlush™ slushed solution is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport. Organ Recovery Prior to organ recovery, EasiSlush™ slushed solution is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery. During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional EasiSlush slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ). Organ Storage/Transport For organ storage/transport, EasiSlush™ slushed solution may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, EasiSlush may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.

EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It meets the USP 34 monograph for Sodium Chloride Irrigation. It is a sterile, nonpyrogenic, isotonic solution that is chilled for the preparation of slushed solution.