ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)

PACKAGE/LABEL DISPLAY PANEL Code 4R1590P 9 Units Fenwal™ Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK ® Unit; TRANSFER-PACK ® Container with ADSOL ® Red Cell Preservation Solution; Integral SEPACELL ® FLEX-EXCEL ® Red Cell Leukocyte Reduction Filter Quadruple For Collection and Processing of 500 mL Blood Sample Diversion System, DONORCARE ® Needle Guard, 16 ga. Ultra Thin Wall Needle Rx only Each unit consists of a PL 146 Plastic primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 2209 Plastic Satellite Container with 110 mL of Adsol Red Cell Preservation Solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL PL 2209 Plastic TRANSFER PACK Containers; one integral SEPACELL FLEX-EXCEL Red Cell Leukocyte Reduction Filter and one empty 450 mL PL 2209 Plastic TRANSFER PACK Container for the storage of AS-1 Red Blood Cells, Leukocytes Reduced. Sterile, non-pyrogenic fluid path. See instructions for use. Store at Controlled Room Temperature (refer to direction insert). Open pouch by tearing across at notch. Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture, provided: l) Units are not removed from foil pouch, or ll) Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once. Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth. Units removed from the foil pouch (that are not returned to the pouch within 12 hours)must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded. FENWAL, BLOOD-PACK, ADSOL, TRANSFER PACK and FLEX-EXCEL are trademarks of Fenwal, Inc. SEPACELL is a trademark of Asahi Kasei Medical Co., Ltd. DONORCARE is a trademark of Noble House Group Pty. Ltd.. PL 146 and PL 2209 are trademarks of Baxter International Inc. Fenwal, Inc. Lake Zurich, IL 60047 USA Made in USA 07-28-12-663 REV: A mfg3 primlbl

• PACKAGE/LABEL DISPLAY PANEL Code 4R1590P 9 Units Fenwal™ Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK ® Unit; TRANSFER-PACK ® Container with ADSOL ® Red Cell Preservation Solution; Integral SEPACELL ® FLEX-EXCEL ® Red Cell Leukocyte Reduction Filter Quadruple For Collection and Processing of 500 mL Blood Sample Diversion System, DONORCARE ® Needle Guard, 16 ga. Ultra Thin Wall Needle Rx only Each unit consists of a PL 146 Plastic primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 2209 Plastic Satellite Container with 110 mL of Adsol Red Cell Preservation Solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL PL 2209 Plastic TRANSFER PACK Containers; one integral SEPACELL FLEX-EXCEL Red Cell Leukocyte Reduction Filter and one empty 450 mL PL 2209 Plastic TRANSFER PACK Container for the storage of AS-1 Red Blood Cells, Leukocytes Reduced. Sterile, non-pyrogenic fluid path. See instructions for use. Store at Controlled Room Temperature (refer to direction insert). Open pouch by tearing across at notch. Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture, provided: l) Units are not removed from foil pouch, or ll) Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once. Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth. Units removed from the foil pouch (that are not returned to the pouch within 12 hours)must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded. FENWAL, BLOOD-PACK, ADSOL, TRANSFER PACK and FLEX-EXCEL are trademarks of Fenwal, Inc. SEPACELL is a trademark of Asahi Kasei Medical Co., Ltd. DONORCARE is a trademark of Noble House Group Pty. Ltd.. PL 146 and PL 2209 are trademarks of Baxter International Inc. Fenwal, Inc. Lake Zurich, IL 60047 USA Made in USA 07-28-12-663 REV: A mfg3 primlbl