{"effective_time":"20100101","id":"5d9533f9-ee81-488b-99d6-e49f44733ee0","openfda":{},"package_label_principal_display_panel":["OXYGEN CERTIFICATE OF ANALYSIS SIMS WELDING SUPPLY QUALITY ASSURANCE PROGRAM VERSION 8 AUGUST 2007 PAGE 128 8.11 CERTIFICATE OF ANALYSIS - OXYGEN USP CERTIFICATE OF ANALYSIS OXYGEN LIQUEFIED CUSTOMER____ DATE______LOT#____________INVOICE#___________________ USP MEDICAL GRADE TEST/REQUIREMENT NF SPECIFICATION LOT ANALYSIS ANALYTICAL METHOD IDENTIFICATION PASS PARAMAGNETISM - SERVOMEX ODOR NO APPRECIABLE ODOR ORGANOLEPTIC CARBON DIOXIDE LESS THAN OR EQUAL TO 0.03% SEE NOTE SEE NOTE CARBON MONOXIDE LESS THAN OR EQUAL TO 0.001% SEE NOTE SEE NOTE ASSAY GREATER THAN OR EQUAL TO 99.6% PARAMAGNETISM - SERVOMEX NOTE: USP/NF EXEMPTS FACILITIES THAT MANUFACTURE OXYGEN USP BY THE AIR LIQUEFACTION PROCESS FROM THE TESTS FOR CARBON DIOXIDE AND CARBON MONOXIDE. OUR OXYGEN USP IS MANUFACTURED BY THE AIR LIQUEFACTION PROCESS THE METHODOLOGY BEING USED TO PERFORM THE USP/NF TEST FOR ASSAY IS INDICATED BELOW: PARAMAGNETIC ANALYZER MODEL: SERVOMEX 5200 SUPPLIER SIGNATURE:_____________________________ DATE:___________________ OXYGEN COA"],"set_id":"2109e767-e651-4868-b3fc-198a2ef24168","spl_product_data_elements":["OXYGEN OXYGEN OXYGEN OXYGEN"],"version":"1","warnings_and_cautions":["WARNINGS AND PRECAUTIONS THIS MATERIAL WAS FILLED IN ACCORDANCE WITH OUR STANDARD OPERATING PROCEDURES UTILIZED FOR THE MANUFACTURE OF MEDICAL GASES. THESE PROCEDURES ENSURE THAT PRODUCTS ARE SAFELY MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICES (cGMP) REGULATIONS AND FDA MEDICAL GAS GUIDELINES FOR MEDICAL GAS CUSTOMERS. FOR NON-MEDICAL CUSTOMERS, THIS MATERIAL IS NOT APPROVED FOR HUMAN DRUG USE."]}