OXYGEN

Air Source Industries Inc
Air Source Industries Inc

FULL PRESCRIBING INFORMATION: CONTENTS*

• OXYGEN COMPRESSED LABEL
• OXYGEN REFRIGERATED LIQUID LABEL
• GENERAL WARNINGS AND PRECAUTIONS
• OXYGEN CERTIFICATE OF ANALYSIS

FULL PRESCRIBING INFORMATION

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP  UN 1072

PRODUCED BY AIR LIQUEFACTION.

WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  STORE AND USE WITH ADEQUATE VENTILATION.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN SERVICE.   CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURES SHOULD NOT EXCEED 52 C (125 F)  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS).

OXYGEN REFRIGERATED LIQUID LABEL

OXYGEN REFRIGERATED LIQUID U.S.P.  UN 1073

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

WARNING: EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.  STORE AND USE WITH ADEQUATE VENTILATION.  KEEP OIL, GREASE, AND COMBUSTIBLES AWAY.  NO SMOKING IN CONTAINER AREA.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE.  DO NOT GET LIQUID IN EYES ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES.  DO NOT DROP OR HANDLE EQUIPMENT ROUGHLY.  USE SUITABLE HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CYLINDER TEMPERATURES SHOULD NOT EXCEED 52 C (125 F)  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS).

FIRST AID:  IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

CAUTION:  USE NO OIL ON VALVE OR CONNECTIONS.  TRANSFILLING OF THIS LIQUID OR GAS IS PROHIBITED.

GENERAL WARNINGS AND PRECAUTIONS

Warning: for emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.  For all other medical applications Rx Only.  Uninterrupted use of high concentrations of oxygen over a long duration without monitoring oxygen content of arterial blood may be harmful.  Uninterrupted use of high concentrations of oxygen for more than 5 hours may be harmful.  Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.

keep oil and grease away

DO NOT REMOVE THIS PRODUCT LABEL

Caution:  Federal Law prohibits dispensing without prescription.  Rx Only

OXYGEN CERTIFICATE OF ANALYSIS

  CUSTOMER ___________________  VENDOR / SUPPLIER ________________________  THIS LETTER IS TO PROVIDE YOU WITH THE
               CERTIFICATION YOU REQUESTED FOR OXYGEN USP LOT NUMBER _______________________ SUPPLIED TO YOU IN
               CYLINDERS / VESSELS BY OUR LOCATION
               
               These cylinders were filled in accordance with the Standard Operating Procedures utilized for the manufacture of Medical Gases.  By
               following these procedures, our location ensures that products are safely manufactured in compliance with FDA’s Current Good Manufacturing Practices
               (cGMP) Regulations.  
               CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84.  THIS
               CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY WITH OTHER PORTIONS OF 21 CFR 210 AND 211, INCLUDING BUT NOT
               LIMITED TO 21 CFR 211.165 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND VESSELS FILLED FROM THESE SUPPLY CYLINDERS.  THESE CYLINDERS ARE
               NOT CERTIFIED FOR INSTRUMENT CALIBRATION.

TEST REQUIREMENT           USP SPECIFICATION                  LOT ANALYSIS
IDENTIFICATION                         PASS
ODOR                                        PASS
CARBON DIOXIDE                    LESS THAT 0.03%
CARBON MONOXIDE                LESS THAT 0.001%
ASSAY                                     GREATER THAN 99.0%

*  NOTE: The USP/NF exempts facilities that manufacture Oxygen USP by the Air Liquefaction process from the tests for Carbon Dioxide and Carbon Monoxide.  
               As our label states, the Oxygen USP being supplied 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 # _________________________
               J 700 a1

REVISION 1.0
               CERTIFICATE OF ANALYSIS - OXYGEN USP