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OXYGEN

Badger Welding Supplies, Inc
Badger Welding Supplies, Inc


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED UN 1072 DO NOT REMOVE THIS PRODUCT LABEL.  OXYGEN U.S.P.  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 VALVE PROTECTIVE CAP IN PLACE WHEN NOT IN USE, IF SO EQUIPPED.  USE IN ACCORDANCE WITH MSDS G1  CONTENTS _______________  SIZE __________ PRESSURE 1900 PSIG AT 70 F MADE IN USA

Rx ONLY

OXYGEN
OXYGEN






OXYGEN REFRIGERATED LIQUID LABEL

OXYGEN REFRIGERATED LIQUID U.S.P. UN 1072  OXYGEN - 2 GROSS WT ___________ LBS OZ NET WT _________________ LBS OZ SIZE__________________ CONTENTS _______________ LITERS

OXYGEN PRODUCED BY AIR LIQUEFACTION  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.

KEEP OIL GREASE AND COMBUSTIBLES AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE.  USE ONLY WITH EQUIPMENT DESIGNATED FOR AND COMPATIBLE WITH OXYGEN AND RATED FOR CYLINDER PRESSURE.  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 SPECIFICALLY DESIGNATED FOR LIQUID CYLINDER MOVEMENT.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH BOC GASES MSDS G-102.

TO BE REFILLED BY A BOC GASES AUTHORIZED FACILITY ONLY.  IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY

CAS 7782-44-7  AIRCO  DO NOT REMOVE THIS PRODUCT LABEL MG1644E LSP 6004E 5/98

OXYGEN

OXYGEN CERTIFICATE OF ANALYSIS

THIS LETTER IS TO PROVIDE YOU WITH THE CERTIFICATION YOU REQUESTED FOR OXYGEN USP, LOT _____________ 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, OR LOCATION ENSURES THAT PRODUCTS ARE SAFELY MANUFACTURED IN COMPLIANCE WITH FDA'S CURRENT GOOD MANUFACTURING PRACTICES (cGMP) REGULATIONS AND FDA MEDICAL GAS GUIDELINES.  CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84.  THIS CERTIFICATION DOES NOT ELIMINATE CUSTOMER'S OBLIGATION TO COMPLY WITH OTHER PORTIONS OF 21 CFR 210 AND 211 INCLUDING BY NOT LIMITED TO 21 CFR 211.265 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND VESSELS FILLED FROM THESE SUPPLY CYLINDERS.  THESE CYLINDERS ARE NOT CERTIFIED FOR INSTRUMENT CALIBRATION PURPOSES.

TEST / REQUIREMENT                        NF SPECIFICATION                    LOT ANALYSIS

IDENTIFICATION                                        PASS

ODOR                                                            NO APPRECIABLE ODOR
CARBON DIOXIDE                                          LESS THAN 0.03%

CARBON MONOXIDE                                LESS THAN OR EQUAL TO 0.001%

ASSAY                                                            GREATER THAN OR EQUAL TO 99.0%

THE METHODOLOGY BEING USED TO PERFORM THE USP / NF TEST FOR ASSAY IS INDICATED BELOW: _____________ PARAMAGNETIC ANALYZER MODEL #________________________  _________________________ THIS METHOD IS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP ORSAT METHOD FOR OXYGEN ASSAY. __________________ ORSAT  SUPPLIER SIGNATURE ____________________ DATE _______________

OXYGEN

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. FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS 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.  TO BE REFILLED BY A BADGER WELDING AUTHORIZED REPRESENTATIVE ONLY.  PRODUCED BY AIR LIQUEFACTION.  RETURN WITH 25 PSIG.

OXYGEN

OXYGEN GAS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:12121-001
Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oxygen Oxygen 99 L

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12121-001-01 141 in 1 CYLINDER
2 NDC:12121-001-02 234 in 1 CYLINDER
3 NDC:12121-001-03 387 in 1 CYLINDER
4 NDC:12121-001-04 643 in 1 CYLINDER
5 NDC:12121-001-05 1738 in 1 CYLINDER
6 NDC:12121-001-06 3511 in 1 CYLINDER
7 NDC:12121-001-07 7051 in 1 CYLINDER
8 NDC:12121-001-08 8552 in 1 CYLINDER
9 NDC:12121-001-09 127400 in 1 DEWAR
10 NDC:12121-001-10 1692697 in 1 TANK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1955-01-01


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