Label: NITROGEN- nitrogen gas

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

Drug Label Information

Updated July 13, 2021

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

  • WARNINGS SECTION

    Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    N2 NF CoA

     

    Messer
    Gases for Life

    Certicate of Analysis - Nitrogen NF

    Product: Nitrogen NF

    Date

     

    Facility Name

     

    Facility Address

     

    Lot#

     

    Batch #

     

    Final Analysis Results

    Analyzer #

    Test/Units

    NF Specs

    Analysis Results

    N/A

    Odor

    None

     

     

    ppm O2

    < 10,000

    (Messer Spec <5.0)

      ppm

     

    ppm CO

    < 10.0

      ppm

     

    ppm THC

    N/A

      ppm

     

    ppm H2O

    N/A

      ppm

     

    ppm CO2

    N/A

      ppm

     

    ppm H2

    N/A

      ppm

    Assay Results

    Nitrogen min %

    > 99.0%

    (Messer Spec >99.999%)

    %

    NT= not tested

    PPM O2 Method Used:                 __________________________

    Manufacturer/

    Model #:                  __________________________

    PPM O2 Method Used: 

    __________________________

    Manufacturer/Model #:   

                  __________________________

    This analyzer has been validated by Messer as acceptable alternatives to the official NF for Nitrogen Assay. Validation study documentation is maintained by Messer at the corporate offices.

    Analyst

    Date

     

     

     

     

    Quality Reviewer

    Date

     

     

     

     

     

    Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

    2.5 January 2019

    ASU-22-06-GAM-Medical Gas Procedures

    Page 1 of 1

    Retention Period – 3 Years

  • INGREDIENTS AND APPEARANCE
    NITROGEN  
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52438-016
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Nitrogen (UNII: N762921K75) (Nitrogen - UNII:N762921K75) Nitrogen995 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52438-016-2025000 L in 1 TANK; Type 0: Not a Combination Product01/01/1960
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576601/01/1960
    Labeler - Messer LLC (001368141)
    Registrant - Messer LLC (001368141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Messer LLC943812438manufacture(52438-016) , api manufacture(52438-016)
    Establishment
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