{"description":["CPDA-1 Blood Bag Unit with in-line WBF Filter (WBF2) and sampling System"],"effective_time":"20260624","how_supplied":["Sterile, non-pyrogenic fluid path, sterilized by steam"],"id":"54fdf83e-f642-1f69-e063-6394a90ab750","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":["87069-736-62"],"product_ndc":["87069-736"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"spl_id":["54fdf83e-f642-1f69-e063-6394a90ab750"],"spl_set_id":["54fdf83e-f641-1f69-e063-6394a90ab750"],"substance_name":["DEXTROSE MONOHYDRATE","ADENINE","SODIUM CITRATE","CITRIC ACID MONOHYDRATE","SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE"],"unii":["LX22YL083G","JAC85A2161","1Q73Q2JULR","2968PHW8QP","593YOG76RN"]},"package_label_principal_display_panel":["whole blood 12 red blood cells 10 plasma 6 leukotrap 25 leukotrap 26 IFU 1 IFU 2 IFU 3"],"set_id":"54fdf83e-f641-1f69-e063-6394a90ab750","spl_product_data_elements":["Leukotrap WB System CPDA-1 Blood Bag Collection System DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE ADENINE ADENINE SODIUM CITRATE ANHYDROUS CITRIC ACID SODIUM CATION CITRIC ACID MONOHYDRATE ANHYDROUS CITRIC ACID SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE PHOSPHATE ION SODIUM CATION"],"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"}