OXYGEN

ADF Welding & Medical, Inc.
ADF Welding & Medical, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP UN 1072  PRESSURE:_______________ PSIG AT 70 F  SIZE _____ CONTENTS:____________________ LITERS

DO NOT REMOVE THIS LABEL  PRODUCED BY AIR LIQUEFACTION RETURN WITH 25 PSIG.

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION Rx ONLY.

CAS 7782-44-7

GENERAL WARNINGS AND PRECAUTIONS

WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USER SHALL SECURE CYLINDER IN USE AND IN STORAGE.  USE IN UPRIGHT POSITION.  CLOSE VALVE AFTER EACH USE.  KEEP PROTECTIVE CAP IN PLACE WHEN NOT IN USE, IF SO EQUIPPED.  USE IN ACCORDANCE WITH MSDS

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION RX ONLY

WARNING: 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 OUT OF REACH OF CHILDREN.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME

REFRIGERATED LIQUID LABEL

OXYGEN REFRIGERATED LIQUID, U.S.P.
               UN 1073 (CRYOGENIC LIQUID)

Produced by Air Liquefaction
               OXYGEN 2

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

For
emergency use only when administered by properly trained personnel for
oxygen deficiency and resuscitation. For all other medical applications
RX only. Warning: Caution Federal Law Prohibits Dispensing without
Prescription. First Aid IN CASE OF FROSTBITE, obtain medical treatment
immediately.

PLEASE REFER TO THE MATERIAL SAFETY DATA SHEET FOR SAFETY AND PRODUCT INFORMATION.
              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.

WARNING!
Uninterrupted use of high concentrations of oxygen over long duration,
without monitoring its effect on oxygen content of arterial blood, may
be harmful. Use only with pressure reducing equipment and apparatus
designed for oxygen. Do not attempt to use on patients who have stopped
breathing, unless used in conjunction with resuscitative equipment.
Keep oil, grease, and combustibles away. Use only with equipment
cleaned for oxygen service. Store and use with adequate ventilation. Do
not get liquid in eyes, on skin or clothing. For liquid withdrawal,
wear face shield and gloves. Do not drop. Use hand truck for container
movement. Avoid spills. Do not walk on or roll equipment over spills.
Close valve after each use and when empty. Use in accordance with
Material Safety Data Sheet.

Part #DB-USP
              Printed by ratermann MFG inc.

\

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