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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.

X°Port Lung Preservation System: The X°Port Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient. The X°Port Lung Preservation System is intended to be used with the X°Port Lung Preservation Solution. The intended organ storage time for the X°Port Lung Preservation System is up to 8 hours. When clinically accepted static hypothermic preservation times are exceeded, the lungs should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient. X°Port Lung Preservation Solution: The X°Port Lung Preservation Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

X°Port Lung Preservation System: The X°Port Lung Preservation System is an organ preservation system. It is designed to store, preserve, and transport human lungs donated for transplantation at 4°C-10°C. The X°Port Lung Preservation System consists of an insulated chamber, phase-change cooling packs, a cradle to hold the lung bag, and a temperature probe and logger. The X°Port Lung Preservation System is designed to be mobile, with wheels and a telescopic handle to maneuver the device throughout its travel. The device is designed to protect the lungs during transport and to display and log the internal temperature on an external screen. Additionally, the internal temperature may be monitored via an application running on a mobile device. X°Port Lung Preservation Solution: The X°Port Lung Preservation Solution is an organ preservation solution used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. X°Port Lung Preservation Solution is a clear, sterile, non-pyrogenic, colloid based, lightly buffered extracellular low potassium dextran solution. During use, the solution is cooled to 4-8°C and is used to perfuse the isolated organ immediately before its removal from the donor and/or immediately after its removal. The solution is then left in the organ vasculature during hypothermic storage and transportation at 4-10°C. The solution is slightly acidic (pH 5.4) to permit long shelf life and is adjusted shortly before use to pH 7.4 by the addition of THAM solution. The solution must be supplemented with 0.5 mmol/l Calcium Chloride prior to use.

The DCX Disposable Cassette, as part of the Kidney Perfusion System, is intended to be used for the pulsatile hypothermic machine perfusion (RM4 Kidney Perfusion System) of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.

The DCX Disposable Cassette, provides a sterile fluid pathway, houses and protects the kidneys during perfusion and it has a gravity flow system which allows circulation of perfusate through the kidneys. The kidneys are placed in an organ chamber filled with perfusate. The perfusate flows from the organ chamber to the pumphead. Then, it is pumped through the heat exchanger to the bubble trap where it is delivered to the cannulated kidney(s). The perfusate then returns to the organ chamber via the kidney vein to repeat the perfusion cycle. The cassette can provide circulation of perfusate to one or two kidneys, attached individually or in bloc.

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.

LungProtect is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

LungProtect is an organ preservation solution used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. LungProtect is a clear, sterile, non-pyrogenic, colloid based, lightly buffered extracellular low potassium dextran solution. During use, the solution is cooled to 4-8°C and is used to perfuse the isolated organ immediately before its removal from the donor and/ or immediately after its removal. The solution is then left in the organ vasculature during storage and transportation. The solution is slightly acidic (pH 5.4) to permit long shelf life and is adjusted shortly before use to pH 7.4 by the addition of THAM solution. The solution is packaged in one-liter (1000 ml) or two-liter (2000 ml) EVA bags, permanently and integrally connected to one (for 1L) or two (for 2L) PVC bags each containing 25 ml (1 mmol) THAM.

The Paragonix KIDNEYvault Portable Renal Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours. Donor kidneys exceeding clinically accepted hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

The KIDNEYvault Portable Renal Perfusion System (KIDNEYvault) device is designed to provide pulsatile perfusion of pre-chilled machine preservation solution through the kidney by means of a mechanical pump and closed fluid circuit integrated within the device and attached to the kidney. Its intended use and principle of operation are the same as the predicate device, LifePort Kidney Perfusion Transporter (K021362), while the differences in the technological characteristics from the predicate are supported by the literature, testing, and the following reference devices: SherpaPak KTS and KIDNEY Assist. To maintain the chilled temperature of the machine preservation solution, the subject KIDNEYvault utilizes the same technology as the first reference device, SherpaPak KTS; whereas certain specifications for the subject device are based on the second reference device, KIDNEY Assist-transport. The subject KIDNEYvault device consists of the following components: 1) KIDNEYvault SherpaCool Pouch and Ribbons Phase Change Material (PCM) (identical to the first reference device) to maintain temperature of the cold machine preservation solution and kidney throughout transportation. The KIDNEYvault device maintains the temperature between 4°C to 8°C throughout preservation and transportation. 2) KIDNEYvault Canister Assembly Proprietary hard shell, polycarbonate nested canister set for the packaging of the donor kidney within cold machine preservation solution and circulation of preservation solution through kidney vasculature. The Canister Assembly incorporates a closed fluid pathway and connections to the donor kidney that draws cold machine preservation solution from the Inner Canister and circulates it through the renal artery of the kidney and exits through the renal vein or ureter back into the Inner Canister. 3) KIDNEYvault Shipper Outer transport shipper which comprises a protective and insulative package. The KIDNEYvault Shipper is a rigid, molded expanded polystyrene (EPS) insulative container into which the KIDNEYvault SherpaCool and KIDNEYvault Canister Assembly are placed. The maintenance of temperature of the donor kidney between 4°C to 8°C is assisted by the EPS insulation of the Shipper, providing insulation from the exterior environment to the interior components and KIDNEYvault SherpaCool. The KIDNEYvault Shipper incorporates a peristaltic pump used to circulate the machine preservation solution through the kidney vascular system. The pump is a peristaltic pump that circulates chilled machine preservation solution (drawn from the Inner Canister) into the renal artery, through the kidney vasculature, and exiting back into the Inner Canister through the renal vein or ureter. The KIDNEYvault Shipper includes a datalogger (connected to a temperature probe and pressure sensor) which records and displays the temperature of the machine preservation solution surrounding the donor kidney and the perfusion pressure within the fluid pathway. 4) KIDNEYvault Cannula The cannula connects to the renal artery of the kidney and the fluid circuit of the KIDNEYvault. There are multiple sizes of round cannulas and oval cannulas for different kidney anatomies.

Servator P Plus SALF Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Servator P Plus SALF Solution is an extracellular electrolyte solution containing Dextran 40. The solution is pre-buffered with 2 mM THAM and pre-supplemented with 0.5 mM CaCl2. Servator P Plus is used for rapid cooling, perfusion, and cold static storage of lungs in connection with transplantation. Administration of the solution at the recommended temperatures will effectively cool the lung to reduce its metabolic requirements. The colloid component, Dextran 40 counteracts tissue oedema and protects the microvasculature against post-ischemic reperfusion injury. Calcium is important to maintain endothelial and epithelial cell integrity and endothelial contractility. The device is buffered with THAM to achieve a physiological ph. that enables safe preservation of lungs for up to 12 hours depending on status of the lung during retrieval. The intended patient population is adult patients in need of a lung transplantation.

BAROguard™ is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for BAROguard™ is up to 8 hours. Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient. Note: Partial lungs can be transported via BAROguard™ by packaging lungs per institutional protocol and UNOS guidelines.

The subject BAROguard device results from modifications made to the cleared LUNGguard (previously named, SherpaPak Lung Preservation System) cleared under K192869. The subject BAROguard device consists of the following components: 1) BAROguard SherpaCool Pouches Phase Change Material (PCM) pouches (identical to the predicate) to maintain temperature of the cold preservation solution and lung throughout transportation. The BAROguard device maintains the temperature between 4°C to 8°C identical to the predicate with the use SherpaCool pouches throughout preservation and transportation. 2) BAROguard Lung Containment Assembly Nested lung containment bags for the packaging of donor lungs and preservation solution. BAROquard Lung Containment Assembly includes pneumatic connections to the donor lung in the inner-most bag, a pneumatic connection to the BAROguard Shipper Airway Pressure Management System, endotracheal connectors to connect the trachea of the donor lungs to the BAROguard Lung Containment Assembly, and tools for the secure attachment of the endotracheal connectors and closure of the BAROguard nested lung containment bags. 3) BAROquard Shipper- Outer transport shipper which comprises a protective and insulative package. The BAROguard Shipper is a rigid, molded expanded polystyrene (EPS) insulative container and into which the SherpaCool pouches and donor lung within the BAROguard Lung Containment Assembly are placed. The maintenance of temperature of the donor lung between 4°C to 8°C is assisted by the EPS insulation of the BAROguard Shipper, providing insulation from the exterior environment to the interior components and BAROguard SherpaCool. The BAROguard Shipper incorporates an Airway Pressure Management System. The Airway Pressure Management System maintains the donor lung airway pressure when connected to the BAROguard Lung Containment Assembly. The BAROquard Shipper includes an off-the-shelf datalogger (connected to a temperature probe and airway pressure sensor) which monitors and displays the temperature of the solution surrounding the donor lungs and the airway pressure of the donor lungs. Although the BAROguard is based on the predicate LUNGguard design, it also includes two new design elements: . Incorporation of a sterile Lung Containment Assembly instead of use of offthe-shelf bags in K192869. . Incorporation of an Airway Pressure Management System to maintain donor lung airway pressure during preservation and transportation.