{"effective_time":"20230412","id":"2b653b36-8c56-4eaf-a243-f5f4a982eaab","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 63323-505-74 FUM 4092 1x 250mL Fresenius Kabi Rx only freeflex Anticoagulant Sodium Citrate Solution, USP EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP pH ADJUSTED WITH CITRIC ACID STERILIZED USING STEAM STERILE FLUID PATH NONPYROGENIC FOR USE WITH CYTAPHERESIS DEVICE ONLY NOT FOR DIRECT INTRAVENOUS INFUSION DO NOT REUSE DO NOT VENT DISCARD UNUSED PORTION DO NOT USE UNLESS SOLUTION IS CLEAR DO NOT USE IF PRODUCT STERILE BARRIER SYSTEM IS COMPROMISED AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED REMOVE RED TAB FOR PRODUCT USE DO NOT USE IF TABS ARE DAMAGED CAUTION –DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE THE OVERWRAP IS A MOISTURE BARRIER THE INNER BAG MAINTAINS STERILITY OF THE PRODUCT STORE AT CONTROLLED ROOM TEMPERATURE PROTECT FROM FREEZING. AVOID EXCESSIVE HEAT MANUFACTURING FACILITY/ MANUFACTURED BY FRESENIUS KABI NORGE AS NO-1753 HALDEN, NORWAY MADE IN NO MANUFACTURER FRESENIUS KABI AG 61346 BAD HOMBURG, GERMANY TEL.: +49 (0)6172 686 0 www.fresenius-kabi.com FUM 4092 01-69-19-001 image01"],"set_id":"ccec1a48-d2f4-4130-93d9-d68502321b1d","spl_product_data_elements":["Sodium Citrate Blood Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID CITRIC ACID MONOHYDRATE"],"spl_unclassified_section":["Anticoagulant Sodium Citrate Solution USP A standalone direction insert does not exist for this product."],"version":"5"}