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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:___________________
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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.
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55586-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55586-001-01 387367 L in 1 TANK 2 NDC:55586-001-02 618485 L in 1 TANK 3 NDC:55586-001-03 683589 L in 1 TANK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1971 Labeler - Sims Welding Supply Co, Inc. (135480783) Registrant - Sims Welding Supply Co, Inc. (135480783) Establishment Name Address ID/FEI Business Operations Sims Welding Supply Co, Inc. 135480783 manufacture