Label: NITROGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 13, 2020

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

  • NITROGEN CERTIFICATE OF ANALYSIS

    Customer

     _______                                                                     Aspen Air

    ________                                                                    1524 Lockwood Road

    ________                                                                    Billings, MT

    This document is the Certificate of Analysis of nitrogen NF Lot # ______________ supplied

    ___ To you is a trailer delivery from our Billings Montana location.

    ___ Picked up by the customer listed above in their trailer

    Following the Aspen Air Medical Gas procedures our location ensures that the nitrogen NF 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 nitrogen NF when the results of the product testing are entered below and the product has been delivered to a registered nitrogen NF customer. This document is in compliance with current FDA guidance.

    Test                             Specification                           Results

    Assay                          ≥ 99.998%                               ____

    Identification                Nitrogen                                  ____

    Odor                            None                                       ____

    Oxygen                       ≤ 10 ppm (0.001%)                 ____

    Carbon Monoxide       ≤ 10 ppm (0.001%)                 ____

    *Trace oxygen analyzer          AIT-21             Model#            Teledyne 3000TAEU

    *Carbon monoxide analyzer   AIT-22             Model#            Teledyne GFC 7001E

    *This analyzer has been validated as an acceptable alternative to the official NF method. The validation study is available for review upon request. Odor Testing was performed using the olfactory method.    

    Supplier signature: __________________________            Date: ____________

    For all nitrogen NF 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 recapped (plugged) for storage                                                             Yes ___ No ___

    Driver signature: ___________________                              Date: ________________

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

    NITROGEN COA

  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42914-010
    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:42914-010-0111000000 L in 1 TANK; Type 0: Not a Combination Product12/15/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20586312/15/2007
    Labeler - Aspen Air U.S., LLC (790650449)
    Registrant - Aspen Air U.S., LLC (790650449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aspen Air U.S., LLC790650449manufacture(42914-010)