OXYGEN by Sims Welding Supply Co, Inc. OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Sims Welding Supply Co, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:___________________

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.

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product 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