Label: NITROGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

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Drug Label Information

Updated January 1, 2010

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  • NITROGEN COMPRESSED LABEL

    NITROGEN COMPRESSED NF UN 1066

    CAUTION;  HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION  Store and use with adequate ventilation  use equipment rated for cylinder pressure  Close valve when not in use and when empty.  Use in accordance with suppliers Material Safety Data Sheet.

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

    Do Not Remove this Product Label

    NITROGEN SHOULDER LABEL


  • NITROGEN 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           NF SPECIFICATION                  LOT ANALYSIS
    IDENTIFICATION                         PASS
    ODOR                                        PASS
    Oxygen                                   LESS THAT 1.0%
    CARBON MONOXIDE                LESS THAT 0.001%
    ASSAY                                     GREATER THAN 99.0%

    The methodology being used to perform the USP / NF Test for
                   Assay is indicated below:   Paramagnetic Analyzer    Model # _________________________
                                                                      Electrochemical Analyzer    Model # _________________________
                                                                           Gas Chromatography Official USP/NF method

    Supplier Signature ____________________________  Date _______________________

    J 700 a2

    NITROGEN COA

  • GENERAL WARNINGS AND PRECAUTIONS

    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 hazards, contraindications, and
    side effects and the precautions to be taken.  Rx Only

  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52849-200
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52849-200-01651 L in 1 CYLINDER
    2NDC:52849-200-025947 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1952
    Labeler - Capweld Inc (033340977)
    Registrant - Capweld Inc (033340977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Capweld Inc033340977manufacture