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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.

Servator M SALF Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation, and eventual transportation, and eventual transplantation into a recipient.

The Servator M SALF is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 rnEq/L, and a pH of approximately 7.4 at room temperature. The primary containers used for the device are PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration. Servator M SALF is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

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

Servator P SALF Solution with THAM is a clear to light yellow, single use only, sterile (by steam sterilization) is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into recipient. The solution is used for organ perfusion and hypothermic preservation. It is an ideal solution for the preservation of lungs. The solution cooled to 4° to 8° C (39° to 46° F) is used to spray the organ isolated immediately after removal from the donor. The colloidal component Dextran 40 protects in particular microvessels from a possible damage caused by the post-ischemic reperfusion, since it prevents pathological leukocyte-endothelial interactions. In addition, Dextran 40 prevents edema and the formation of thrombi. The primary containers used for the device are: - 1) PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration. - 2) Clear glass bottles 25ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.

Servator C SALF Solution is intended for flushing and cold storage of hearts at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Servator C SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the recipient. The solution is slightly alkaline (pH 7.3 ± 0.2 at 20°C), slightly hypertonic (approximate calculated osmolarity 242-368 mOsmol/L) with low viscosity (1.15 cSt), and has a high buffering capacity (acidic approximately 11 mmol, alkaline approximately 7 mmol). After removal from refrigerated storage (2°-8°C or 36°-46°F), the cold solution is used to flush the heart immediately before removal from the donor and/or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation. The primary containers used for the device are PVC free bags in 1000ml, therefore they are free of phthalates. The containers are in accordance with the reference European Pharmacopoeia and USP Pharmacopeia.

Servator B SALF Solution is intended 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.

Servator B SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic flushing and preservation of organs. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP). The primary containers used for the device are PVC free bags 1000ml and 2000ml; therefore, they are free of phthalates. The bags must be chilled to between 2° and 6° C (36° to 43° F) prior to use. The solution may be used without any point of use filtration. The Servator B SALF Solution is intended for perfusion and flushing donor kidneys, liver and pancreas immediately before or immediately after removal from a dead donor or immediately after removal from a living donor. The solution remains in the organ vessels during hypothermic storage and transportation. Servator B SALF Solution is meant for the cold storage of the organ and is not indicated for hypothermic preservation with continuous mechanical perfusion.

The Servator H SALF solution is indicated for perfusion and flushing 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 (not for continuous perfusion) to the recipient.

The Servator H SALF solution is intended for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal form the donor or immediately after removal from the donor. The solutions is left in the organ vasculature during hypotermic storage and transportation (not for continuous perfusion) to the recipient. Servator H SALF solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive duffering of the extrcellular space by means of histidine/histidine HCI, so as to prolong the period for which organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the Servator H SALF solution is due to the sodium and potassium. The composition of the Servator H SALF is similar to that of extracellular fluid. All of the components of the Servator H SALF solution occur naturally in the body.