SPL Set ID: 58bdabc8-283a-47bd-8abe-dd9284f3f497

The Reveos SELECT set has been evaluated for use with the Reveos system. The blood and fluid pathways of the blood bag set are steam-sterilized and are non-pyrogenic. The blood bag set is intended for use by appropriately trained phlebotomists who collect whole blood and by blood center personnel who process whole blood using the Reveos system. The formulas of the active ingredients are provided in Tables 1 and 2. Table 1: CPD Active Ingredients Ingredients Molecular Formula Molecular Weight Dextrose (anhydrous) C 6 H 12 O 6 180.16 g/mol Trisodium Citrate (dihydrate) C 6 H 5 Na 3 O 7 2H 2 O 294.10 g/mol Citric Acid (monohydrate) C 6 H 8 O 7 H 2 O 210.14 g/mol Sodium Dihydrogen Phosphate (dihydrate) NaH 2 PO 4 2H 2 O 156.01 g/mol Water for Injection H 2 O 18.02 g/mol Each 70 mL of CPD contains: Dextrose (anhydrous) 1.624 g, Trisodium Citrate (dihydrate) 1.841 g, Citric Acid (monohydrate) 0.229 g, Sodium Dihydrogen Phosphate (dihydrate) 0.176 g, and water for injection up to 70 mL. Table 2: AS-5 Active Ingredients Ingredients Molecular Formula Molecular Weight Dextrose (anhydrous) C 6 H 12 O 6 180.16 g/ mol Sodium Chloride NaCl 58.44 g/mol Mannitol C 6 H 14 O 6 182.17 g/mol Adenine C 5 H 5 N 5 135.13 g/mol Water for injection H 2 O 18.02 g/mol Each 111 mL of AS-5 contains: Dextrose (anhydrous) 0.908 g, Sodium Chloride 0.973 g, Mannitol 0.583 g, Adenine 0.035 g, and water for injection up to 111 mL. The PVC plasticized with DEHP bags are not made with natural rubber latex. The bags contain materials that have been tested to demonstrate the suitability of the containers for storing pharmaceutical solutions. The bags are nontoxic and biologically inert. The blood bag set is a closed system and is not dependent upon entry of external air during administration. The blood bag set is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.