{"effective_time":"20100101","id":"d9f4b162-4a2b-46ad-9024-8a9a3ebafd8c","openfda":{},"package_label_principal_display_panel":["NITROGEN COMPRESSED LABEL NITROGEN COMPRESSED NF UN 1066 CAUTION; HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION Store and use with adequate ventilation use equipment rated for cylinder pressure Close valve when not in use and when empty. Use in accordance with suppliers Material Safety Data Sheet. FIRST AID: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. Do Not Remove this Product Label NITROGEN SHOULDER LABEL","NITROGEN CERTIFICATE OF ANALYSIS CUSTOMER ___________________ VENDOR / SUPPLIER ________________________ THIS LETTER IS TO PROVIDE YOU WITH THE CERTIFICATION YOU REQUESTED FOR OXYGEN USP LOT NUMBER _______________________ SUPPLIED TO YOU IN CYLINDERS / VESSELS BY OUR LOCATION These cylinders were filled in accordance with the Standard Operating Procedures utilized for the manufacture of Medical Gases. By following these procedures, our location ensures that products are safely manufactured in compliance with FDA’s Current Good Manufacturing Practices (cGMP) Regulations. CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84. THIS CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY WITH OTHER PORTIONS OF 21 CFR 210 AND 211, INCLUDING BUT NOT LIMITED TO 21 CFR 211.165 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND VESSELS FILLED FROM THESE SUPPLY CYLINDERS. THESE CYLINDERS ARE NOT CERTIFIED FOR INSTRUMENT CALIBRATION. TEST REQUIREMENT NF SPECIFICATION LOT ANALYSIS IDENTIFICATION PASS ODOR PASS Oxygen LESS THAT 1.0% CARBON MONOXIDE LESS THAT 0.001% ASSAY GREATER THAN 99.0% The methodology being used to perform the USP / NF Test for Assay is indicated below: Paramagnetic Analyzer Model # _________________________ Electrochemical Analyzer Model # _________________________ Gas Chromatography Official USP/NF method Supplier Signature ____________________________ Date _______________________ J 700 a2 NITROGEN COA"],"set_id":"f73025e5-327e-41df-ad05-9ba04bb84645","spl_product_data_elements":["NITROGEN NITROGEN NITROGEN NITROGEN"],"version":"1","warnings_and_cautions":["GENERAL WARNINGS AND PRECAUTIONS WARNING: Administration of nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration and with hazards, contraindications, and side effects and the precautions to be taken. Rx Only"]}