OXYGEN GAS [MESSER CANADA LTD]

OXYGEN GAS [MESSER CANADA LTD]
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NDC 52003-911-20
Set ID cfef728e-5f35-7794-5a85-fc144c28ea43
Category PRESCRIPTION ANIMAL DRUG LABEL
Packager Messer Canada Inc.
Generic Name
Product Class
Product Number
Application Number NADA141373
  • WARNINGS AND PRECAUTIONS SECTION

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    O2 USP CoA

     

    Messer
    Gases for Life

    Certicate of Analysis - Oxygen USP

    Product: Oxygen USP

    Date

     

    Facility Name

     

    Facility Address

     

    Lot#

     

    Batch #

     

    Final Analysis Results

    Analyzer #

    Test/Units

    USP Specs

    Analysis Results

    N/A

    Odor

    None

     

     

    % O2

    > 99.0%
    (Messer Spec >99.50%)

      %

     

    ppm H2O

    N/A

      ppm

     

    ppm THC

    N/A

      ppm

    N/A

    % CO

    ≤ .001

      ***

    N/A

    % CO2

    ≤ .03

      ***

    NT= not tested

    *** = This product was manufactured by Air Liquefaction and testing is exempt under the USP compendium.

    The methodology used to perform the USP test:

         Paramagnetic Analyzer Manufacturer / Model# : _______________________________________________

    This analyzer has been validated by Messer as acceptable alternatives to the official USP for Oxygen 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 USP 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
    OXYGEN  
    oxygen gas
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:52003-911
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen995 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52003-911-2018144 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14137301/01/1960
    Labeler - Messer Canada Inc. (201613189)
    Registrant - Messer Canada Inc. (201613189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Messer Canada Inc.244231937manufacture, api manufacture

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