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Name:Nitrogen
Manufacturer:Badger Welding Supplies, Inc
Category:Prescription Marketed Drugs


NITROGEN  - nitrogen gas 
Badger Welding Supplies, Inc

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NITROGEN NF COMPRESSED LABEL

NITROGEN COMPRESSED UN 1066 NON-FLAMMABLE -2  NITROGEN N.F. CAUTION: HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION.  STORE AND USE WITH ADEQUATE VENTILATION.  USE EQUIPMENT RATED FOR CYLINDER PRESSURE.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH THE SPECIFIC MATERIAL SAFETY DATA SHEET (MSDS) FOR THIS PRODUCT. www.lindeus.com.  Rx ONLY.  DO NOT REMOVE THIS PRODUCT LABEL.  CAS 7727-37-9 TO BE REFILLED BY A LINDE AUTHORIZED FACILITY ONLY.  PRESSURE _______ PSIG AT 70 F  SIZE_____  CONTENTS___________ LITERS  RETURN WITH 25 PSIG  LSP 5922E MG 815G 11/07 MADE IN USA

NITROGEN SHOULDER LABEL

NITROGEN NF REFRIGERATED LIQUID LABEL

NITROGEN, REFRIGERATED LIQUID N.F. UN 1977 NON-FLAMMABLE GAS - 2

GROSS WT__________ LBS OZ NET WT. _____________ LBS OZ SIZE ________ CONTENTS _________ LITERS

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION  WARNING" EXTREMELY COLD LIQUID AND GAS UNDER PRESSURE.  CAN CAUSE RAPID SUFFOCATION.  CAN CAUSE SEVERE FROSTBITE.  STORE AND USE WITH ADEQUATE VENTILATION.  USE ONLY WITH EQUIPMENT DESIGNATED FOR NITROGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  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 DESIGNED FOR LIQUID CYLINDER MOVEMENT.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH BOC GASES MSDS G-101.  DO NOT VENT CYLINDER IN CONFINED SPACE.  DO NOT ENTER CONFINED SPACE WHERE GAS MAY BE PRESENT UNLESS AREA HAS BEEN WELL VENTED AND SPACE HAS BEEN TESTED FOR ADEQUATE OXYGEN LEVEL (AT LEAST 19%) WITH AN APPROVED OXYGEN MEASURING INSTRUMENT, OR WEARING AN APPROVED AIR SUPPLIED BREATHING APPARATUS, WITH A SECOND PERSON PRESENT, SIMILARLY EQUIPPED.

Rx ONLY TO BE REFILLED BY A BOC GASES AUTHORIZED FACILITY ONLY.  CAS 7727-37-9 AIRCO DO NOT REMOVE THIS PRODUCT LABEL MG 1647E LSP 6087C 5/98

NITROGEN LIQUID LABEL

NITROGEN NF CERTIFICATE OF ANALYSIS

THIS LETTER IS TO PROVIDE YOU WITH THE CERTIFICATION YOU REQUESTED FOR NITROGEN NF, 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

OXYGEN                                          LESS THAN 1.0%

CARBON MONOXIDE                        LESS THAN OR EQUAL TO 10 PPM

ASSAY                                             GREATER THAN OR EQUAL TO 99.0%

THE METHODOLOGY BEING USED TO PERFORM THE NF TEST FOR ASSAY IS INDICATED BELOW: _____________ PARAMAGNETIC ANALYZER MODEL #________________________  _________________________ ELECTROCHEMICAL ANALYZER MODEL # ___________________________   THESE ANALYZERS HAVE BEEN VALIDATED AS ACCEPTABLE ALTERNATIVES TO THE OFFICIAL NF GAS CHROMATOGRAPHY METHOD FOR NITROGEN ASSAY.  VALIDATION STUDY DOCUMENTATION IS AVAILABLE.  __________________ GAS CHROMATOGRAPHY OFFICIAL USP / NF METHOD  SUPPLIER SIGNATURE ____________________ DATE _______________

NITROGEN COA

GENERAL WARNINGS AND PRECAUTIONS

WARNING: ADMINISTRATION OF NITROGEN NF MAY BE HAZARDOUS OR CONTRAINDICATED. FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF NITROGEN NF AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS AND SIDE EFFECTS, AND THE PRECAUTIONS TO BE TAKEN.

FIRST AID: IF INHALED, REMOVE TO FRESH AIR.  IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION.  IF BREATHING IS DIFFICULT, GIVE OXYGEN USP.  CALL A PHYSICIAN.  IN CASE OF FROSTBITE, OBTAIN IMMEDIATE MEDICAL ATTENTION. DO NOT REMOVE THIS PRODUCT LABEL.


NITROGEN 
nitrogen gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12121-006
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGEN (NITROGEN) NITROGEN 99 L  in 100 L
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12121-006-01 361 L in 1 CYLINDER None
2 NDC:12121-006-02 597 L in 1 CYLINDER None
3 NDC:12121-006-03 1132 L in 1 CYLINDER None
4 NDC:12121-006-04 3200 L in 1 CYLINDER None
5 NDC:12121-006-05 6456 L in 1 CYLINDER None
6 NDC:12121-006-06 148 L in 1 CYLINDER None
7 NDC:12121-006-07 5 L in 1 DEWAR None
8 NDC:12121-006-08 10 L in 1 DEWAR None
9 NDC:12121-006-09 20 L in 1 DEWAR None
10 NDC:12121-006-10 30 L in 1 DEWAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/1955

Labeler - Badger Welding Supplies, Inc (023314099)
Registrant - Badger Welding Supplies, Inc (023314099)
Establishment
Name Address ID/FEI Operations
Badger Welding Supplies, Inc 023314099 manufacture

Revised: 01/2010 Badger Welding Supplies, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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