Nitrogen

Dosage Form: gas

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 NF REFRIGERATED LIQUID LABEL

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

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION
DO NOT CHANGE OR FORCE FIT CONNECTIONS
Rx only

WARNING: Administration of Nitrogen 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 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.

WARNING: EXTREMELY COLD LIQUID AND GAS UNDER PRESSURE. 
CAN CAUSE RAPID SUFFOCATION.
CAN CAUSE SEVERE FROSTBITE.

Store and use with adequate ventilation.
Do not get liquid in eyes, or on skin or clothing.
For liquid withdraw, wear face shield and gloves.
Do not drop. Use suitable hand truck for container movement.
Cylinder temperature should not exceed 52° C (125° F).
Close valve after each use and when empty.
Use a back flow preventive device in the piping.
Use in accordance with the Material Safety Data Sheet (MSDS).

FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.

IN CASE OF FROSTBITE, obtain medical treatment immediately.

CAS: 7727-37-9
DO NOT REMOVE THIS PRODUCT LABEL.

BADGER WELDING SUPPLIES, INC.
101 SOUTH DICKINSON STREET
MADISON, WI 53703

43549  (05/05)




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 _______________

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 LABEL 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
Packaging
# Item Code Package Description
1 NDC:12121-006-11 260 L in 1 CYLINDER
2 NDC:12121-006-03 1132 L in 1 CYLINDER
3 NDC:12121-006-05 6456 L in 1 CYLINDER
4 NDC:12121-006-06 148 L in 1 CYLINDER
5 NDC:12121-006-07 5 L in 1 DEWAR
6 NDC:12121-006-08 10 L in 1 DEWAR
7 NDC:12121-006-09 20 L in 1 DEWAR
8 NDC:12121-006-10 30 L in 1 DEWAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205766 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(12121-006)
Establishment
Name Address ID/FEI Operations
Linde LLC 945417111 manufacture(12121-006)
Revised: 10/2014
 
Badger Welding Supplies, Inc



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