Belzer UW® Cold Storage Solution Directions for Preparation and Use Not for Direct Injection or Intravenous Infusion Description: Belzer UW® Cold Storage Solution (UW Solution) composition is: Pentafraction Lactobionic Acid (as Lactone) Potassium Phosphate monobasic Magnesium Sulfate heptahydrate Raffinose pentahydrate Adenosine Allopurinol Total Glutathione Potassium Hydroxide Sodium Hydroxide, 5N Water for Injection Belzer UW® Cold Storage Solution is a clear to light yellow, sterile, non-pyrogenic 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. Actions: Belzer UW® Cold Storage Solution must be cooled to 2° to 6°C (36° to 43°F) prior to use. The cold solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation. Belzer UW® Cold Storage Solution is to be used for cold storage of the organ and is not acceptable for continuous machine perfusion. Administration of Belzer UW® Cold Storage Solution, at the recommended temperature, will effectively cool the organ and lower its metabolic requirements. Intended Use: Belzer UW® Cold Storage 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. Contraindications: There are no known contraindications when used as

NOT INTENDED FOR SYSTEMIC ADMINISTRATION BY DIRECT INJECTION OR INTRAVENOUS INFUSION. NOT FOR IN SITU FLUSHING OF ORGANS IN LIVING DONORS OR PATIENTS. DO NOT RE-USE. RE-USE OF TRANSPLANT SOLUTION MAY CAUSE INFECTION OR SEROLOGICAL CROSS CONTAMINATION. Precautions: The donor organ must be flushed free of the Belzer UW® Cold Storage Solution prior to the reperfusion. The organ must be flushed with physiological solution to prevent occurrence (in the recipient) of potentially serious cardiovascular complications such as hyperkalemic cardiac arrest or bradyarrhythmia. This is necessary because of...

RM/N 4107 Rev. 032321 Glutathione, one of the components of Belzer UW® Cold Storage Solution, oxidizes during storage. If desired, an additional 0.922 g/L (3 mmole/L) of glutathione may be added if Transplant Center policy or Surgical Personnel requirements call for its use. (Boudjema et al, Transpl. Proc. 23[5]1991; Merion et al, Transpl. Proc. 23[4]1991). Remove protective cap from the bag outlet port, designated as delivery set port. Insert the spike from the administration set into the bag port with a twisting motion. Open clamp on administration set. Hold the administration set vertically...

500 mL in 500 mL bags, shelf carton of 6; 1000 mL in 1-liter bags, shelf carton of 10; 2000 mL in 2-liter bags, shelf carton of 5. Store Belzer UW® Cold Storage Solution indoors at temperatures controlled between 2° and 25°C (36° and 77°F) until use. Avoid excessive heat. Do not freeze the solution, and do not use if frozen. Do not use if discolored or if obvious particulate matter, precipitates, or contamination are evident in the solution. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Manufactured by: Preservation Solutions, Inc. 1099 Proctor Drive...