{"description":["Leukotrap RC System CP2D/AS-3 - Triple blood bag unit with In-Line RC2D filter and sampling system"],"effective_time":"20260703","how_supplied":["Sterile, Non-pyrogenic fluid pathway. Sterilized by Steam"],"id":"55b55143-e8d9-4051-e063-6394a90a6067","intended_use_of_the_device":["For collection of 500ml of whole blood and preapration of red blood cells and plasma or red blood cells, plasma and platelets with pre-storage leukocyte reduction of red blood cells."],"openfda":{"application_number":["BN820915"],"brand_name":["Leukotrap RC System"],"generic_name":["CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM"],"is_original_packager":[true],"manufacturer_name":["GVS TM INC"],"package_ndc":["87069-129-63"],"product_ndc":["87069-129"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"spl_id":["55b55143-e8d9-4051-e063-6394a90a6067"],"spl_set_id":["4c0dec79-1648-1cfd-e063-6394a90a88cc"],"substance_name":["DEXTROSE, UNSPECIFIED FORM"],"unii":["IY9XDZ35W2"]},"package_label_principal_display_panel":["Bag label 1 Bag label 2 Bag label Pouch label Case Label IFU IFU IFU"],"set_id":"4c0dec79-1648-1cfd-e063-6394a90a88cc","spl_product_data_elements":["Leukotrap RC System CP2D/AS-3 Anticoagulant and Additive System DEXTROSE, UNSPECIFIED FORM ANHYDROUS DEXTROSE CITRIC ACID MONOHYDRATE WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM CITRATE"],"storage_and_handling":["Store at room temperature. Unused bags in opened pouches may be kept 30 days by folding and securing open end of pouch to prevent possible loss of moisture."],"version":"3"}