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Name:Nitrogen
Manufacturer:Adf Welding & Medical, Inc.
Category:Prescription Marketed Drugs


NITROGEN  - nitrogen gas 
ADF Welding & Medical, Inc.

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NITROGEN REFRIGERATED LIQUID LABEL

NITROGEN REFRIGERATED LIQUID NF UN 1977 NON-FLAMMABLE GAS  CONTENTS ________________ LOT NUMBER ________________  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION  DO NOT REMOVE THIS PRODUCT LABEL  WARNING Rx ONLY.  PLEASE REFER TO THE MATERIAL SAFETY DATA SHEET FOR SAFETY AND PRODUCT INFORMATION

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.

PART # DB-NNF PRINTED BY RATERMANN MFG INC.  925-606-2949

LIQUID NITROGEN LABEL

GENERAL WARNINGS AND PRECAUTIONS

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, FREQUENCY, AND DURATION OF ADMINISTRATION, AND THE HAZARDS CONTRAINDICATIONS AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN.

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 ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES.  DO NOT DROP.  USE HAND TRUCK FOR CONTAINER MOVEMENT.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS).

NITROGEN COMPRESSED LABEL

NITROGEN COMPRESSED NF UN 1066 NON-FLAMMABLE GAS - 2 DO NOT REMOVE THIS PRODUCT LABEL

CONTENTS ________ PRESSURE ____________ CAUTION: HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION.  STORE AND USE WITH ADEQUATE VENTILATION.  USER SHALL SECURE CYLINDER IN USE AND IN STORAGE.  USE IN UPRIGHT POSITION.  USE ONLY WITH EQUIPMENT DESIGNATED FOR NITROGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  CLOSE VALVE AFTER EACH USE.  KEEP VALVE PROTECTIVE CAP IN PLACE WHEN NOT IN USE IF SO EQUIPPED.  USE IN ACCORDANCE WITH MSDS.  CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.  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.  FIRST AID: IF INHALED REMOVE TO FRESH AIR.  IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION.  IF BREATHING IS DIFFICULT GIVE OXYGEN, CALL A PHYSICIAN.  CAS 7727-37-9 RETURN WITH 25 PSIG.  LABEL 14

NITROGEN SHOULDER LABEL

NITROGEN CERTIFICATE OF ANALYSIS


               CUSTOMER ___________________  VENDOR / SUPPLIER ________________________  THIS LETTER IS TO PROVIDE YOU WITH THE
               CERTIFICATION YOU REQUESTED FOR NITROGEN NF 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 THAN 1.0%
CARBON MONOXIDE                LESS THAT 10 PPM
ASSAY                                     GREATER THAN 99.0%


              
The methodology being used to perform the NF Test for
               Assay is indicated below:   Paramagnetic Analyzer    Model # ________________________ ELECTROCHEMICAL ANALYZER MODEL #________________ GAS CHROMATOGRAPHY OFFICIAL USP / NF METHOD

NITROGEN COA


NITROGEN 
nitrogen gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64922-240
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:64922-240-01 7400 L in 1 CYLINDER None
2 NDC:64922-240-02 160 L in 1 DEWAR None
3 NDC:64922-240-03 180 L in 1 DEWAR None
4 NDC:64922-240-04 20 L in 1 DEWAR None
5 NDC:64922-240-05 30 L in 1 DEWAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/1990

Labeler - ADF Welding & Medical, Inc. (609900782)
Registrant - ADF Welding & Medical, Inc.ADF Welding & Medical, Inc. (609900782)
Establishment
Name Address ID/FEI Operations
ADF Welding & Medical, Inc. 609900782 manufacture

Revised: 01/2010 ADF Welding & Medical, Inc.



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


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