Label: NITROGEN - nitrogen gas 

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

Drug Label Information

Updated 01/10

If you are a consumer or patient please visit this version.

  • NITROGEN CERTIFICATE OF ANALYSIS

    THIS DOCUMENT IS THE CERTIFICATE OF ANALYSIS OF NITROGEN NF LOT # ______________________ SUPPLIED TO YOU IN A TRAILER FROM OUR BILLINGS MONTANA LOCATION OR PICKED UP BY THE CUSTOMER LISTED ABOVE IN THEIR TRAILER.  FOLLOWING THE ASPEN AIR MEDICAL GAS PROCEDURES OUR LOCATION ENSURES THAT THE OXYGEN USP PRODUCT IS MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS AND THE FDA'S MEDICAL GAS GUIDELINES.  THIS DOCUMENT IS INTENDED TO SERVE AS A CERTIFICATE OF ANALYSIS FOR THE OXYGEN USP WHEN THE RESULTS OF THE PRODUCT TESTING ARE ENTERED BELOW AND THE PRODUCT HAS BEEN DELIVERED TO A REGISTERED OXYGEN USP CUSTOMER.  THIS DOCUMENT IS IN COMPLIANCE WITH CURRENT FDA GUIDANCE

    TEST                      SPECIFICATIONS                    RESULTS

    ASSAY                    GREATER THAN 99.998%

    IDENTIFICATION    NITROGEN

    ODOR                        NONE

    OXYGEN             LESS THAN 0.001%

    CARBON MONOXIDE    LESS THAN 0.001%

    THE METHODOLOGY USED FOR PERFORMING THE USP TEST FOR ASSAY AND IDENTIFICATION IS THE PARAMAGNETIC ANALYZER MODEL # TELEDYNE 2010 MA.  THIS ANALYZER HAS BEEN VALIDATED AS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP METHOD FOR OXYGEN ASSAY AND IDENTIFICATION.  THE VALIDATION STUDY IS AVAILABLE FOR REVIEW UPON REQUEST.  ODOR TESTING WAS PERFORMED BY THE OLFACTORY METHOD.  SUPPLIER SIGNATURE _________________________ DATE _________________

    NUMBER 33 110 A1 - REVISION DATE 05/01/08

    NITROGEN COA

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  • GENERAL PRECAUTIONS

    If this NITROGEN NF is not delivered to a properly registered
    user the product is “Not approved for human drug use”.

    This product has been produced by the air liquefaction
    process and is exempt from these tests as stated in the USP / NF monograph for
    NITROGEN

    FOR ALL NITROGEN N INSTALLATIONS THE DRIVER SHALL ENSURE AND DOCUMENT THE FOLLOWING: HOSE CAPS (PLUGS) IN PLACE PRIOR TO DELIVERY YES/NO, GASKETS ARE SUITABLE FOR USE OR NEW YES/NO, HOSE PURGED PRIOR TO FILLING THE VESSEL YES/NO, HOSE RE-CAPED (PLUGGED) FOR STORAGE YES/NO.  DRIVER SIGNATURE:____________________ DATE:_________________

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  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42914-010
    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 Marketing Start Date Marketing End Date
    1 NDC:42914-010-01 11000000 L in 1 TANK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved medical gas 12/15/2007
    Labeler - Aspen Air US Corp (790650449)
    Registrant - Aspen Air US Corp (790650449)
    Establishment
    Name Address ID/FEI Business Operations
    Aspen Air US Corp 790650449 manufacture
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