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  5. Label Information: Oxygen

FDA Label for Oxygen

View Indications, Usage & Precautions

Table of Contents

    1. OXYGEN CERTIFICATE OF ANALYSIS
    2. WARNINGS AND PRECAUTIONS

Oxygen Product Label

The following document was submitted to the FDA by the labeler of this product Sims Welding Supply Co, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - Sims ws coa o2

OXYGEN COA - Sims ws coa o2


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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