OXYGEN - oxygen gas 
Sims Welding Supply Co, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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:___________________

OXYGEN COA

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.

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55586-001
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55586-001-01387367 L in 1 TANK
2NDC:55586-001-02618485 L in 1 TANK
3NDC:55586-001-03683589 L in 1 TANK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1971
Labeler - Sims Welding Supply Co, Inc. (135480783)
Registrant - Sims Welding Supply Co, Inc. (135480783)
Establishment
NameAddressID/FEIBusiness Operations
Sims Welding Supply Co, Inc.135480783manufacture

Revised: 1/2010
Document Id: 5d9533f9-ee81-488b-99d6-e49f44733ee0
Set id: 2109e767-e651-4868-b3fc-198a2ef24168
Version: 1
Effective Time: 20100101
 
Sims Welding Supply Co, Inc.