{"description":["CPDA-1 Blood Bag Unit with In-Line WBF Filter (WBF2) and Sampling System"],"effective_time":"20260624","how_supplied":["Sterile, nonpyrogenic fluid path. Sterilized by steam."],"id":"54fd8a72-0528-df0c-e063-6294a90abe75","intended_use_of_the_device":["Intended for the collection of whole blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction."],"openfda":{"application_number":["BN800077"],"brand_name":["Leukotrap WB System"],"generic_name":["CPDA-1 BLOOD BAG COLLECTION SYSTEM"],"is_original_packager":[true],"manufacturer_name":["GVS TM INC"],"package_ndc":["87069-136-62"],"product_ndc":["87069-136"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"spl_id":["54fd8a72-0528-df0c-e063-6294a90abe75"],"spl_set_id":["54fd8a72-0527-df0c-e063-6294a90abe75"],"substance_name":["DEXTROSE MONOHYDRATE","SODIUM CITRATE","SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE","ADENINE","CITRIC ACID MONOHYDRATE"],"unii":["LX22YL083G","1Q73Q2JULR","593YOG76RN","JAC85A2161","2968PHW8QP"]},"package_label_principal_display_panel":["Bag label Bag label 2 Bag label 3 Pouch label Case Label IFU 1 IFU 2 IFU 3"],"set_id":"54fd8a72-0527-df0c-e063-6294a90abe75","spl_product_data_elements":["Leukotrap WB System CPDA-1 Blood Bag Collection System DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CITRATE ANHYDROUS CITRIC ACID SODIUM CATION SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE PHOSPHATE ION SODIUM CATION ADENINE ADENINE CITRIC ACID MONOHYDRATE ANHYDROUS CITRIC ACID"],"storage_and_handling":["Store at room temperature, avoid excessive heat, protect from freezing. Unused bags in opened pouch may be kept up to 30 days by folding and securing open end of pouch to prevent possible loss of moisture."],"version":"1"}