{"description":["CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter (WBF2) and Sampling System"],"effective_time":"20260703","how_supplied":["Sterile, nonpyrogenic fluid path. Sterilized by steam."],"id":"55b57873-3c3e-0ce2-e063-6294a90aa6ce","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":["BN820915"],"brand_name":["Leukotrap WB system - CP2D"],"generic_name":["CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM"],"is_original_packager":[true],"manufacturer_name":["GVS TM INC"],"package_ndc":["87069-726-62"],"product_ndc":["87069-726"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"spl_id":["55b57873-3c3e-0ce2-e063-6294a90aa6ce"],"spl_set_id":["42ece7e1-1da1-7e5a-e063-6294a90ac803"],"substance_name":["DEXTROSE, UNSPECIFIED FORM"],"unii":["IY9XDZ35W2"]},"package_label_principal_display_panel":["Bag label Bag label red blood cells Bag label whole blood pouch label case label IFU 1 IFU -2 IFU -3"],"set_id":"42ece7e1-1da1-7e5a-e063-6294a90ac803","spl_product_data_elements":["Leukotrap WB system - CP2D CP2D/AS-3 Anticoagulant and Additive System CITRIC ACID MONOHYDRATE DEXTROSE, UNSPECIFIED FORM ANHYDROUS DEXTROSE SODIUM CITRATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE WATER"],"storage_and_handling":["If moisture is observed on the outside of the collection system when removed from the cellophane pouch, subsequent handling and storage of an unused set within the foil pouch could encourage the growth of mold on the base label. Do not remove bag(s) from the foil pouch until ready to use. Unused bags in opened foil pouches may be kept 30 days by folding and SECURING open end of pouch to prevent possible loss of moisture. Store at room temperature. Avoid excessive heat, protect from freezing."],"version":"2"}