OXYGEN GAS [PRAXAIR MEXICO, S. DE R.L. DE C.V]

OXYGEN GAS [PRAXAIR MEXICO, S. DE R.L. DE C.V]
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NDC 72223-002-01
Set ID a207ab81-e0ab-4d05-92f8-c796c722dad6
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Praxair Mexico, S. de R.L. de C.V
Generic Name
Product Class
Product Number
Application Number NDA210844
  • PRINCIPAL DISPLAY PANEL

    PRAXAIR                              Track No: 012

    Haciendo nuestro planeta mds productive

    Certificate of Analysis (COA)

    PRAXAIR MEXICO S. de R.L. de C.V.

    700 Via Matamoros drive, Garza Cantu

    San Nicolas de los Garza, Nuevo Leon,

    64550 Mexico

    Oxygen USP NDA:                            589381                  Customer Name:              Praxair Inc – Harlingen Tx

    FDA Establishment Identifier:            301258051             Praxair Number:               6010667

    DUNS Number:                                 812953909

    LIQUID OXYGEN USP

    Batch Number:

    OXMIS IC0917 MIS LOX 01 1026

    Order:                   Lot Number:                                                                      Shipping Container:

    98579309              OX MIS 101017 PRXM481 0053                                            481

    Expiration date:                2018 01 09

    This product described in this document meets the requirements of the United States Pharmacopeia 40th edition, 2017, and specifications of Praxair Mexico, S. de R.L. de C.V.

    Component                        Specification                     Analytical ResultAnalytical Method1Analyzer Used

    Assay                                    NLT 99.5% by volume     99.89%v/v                           Paramagnetic                    Servomex 4100

    Identification                     Positive                                Positive                                Paramagnetic                    Servomex 4100

    Tester’s Signature:           XXXXXXXXXXXXXXXXXXXXXX

    Reviewer’s Signature:    XXXXXXXXXXXXXXXXXXXXXX

                                                    Quality Assurance Reviewer

    Notes:1.  Liquid oxygen produced by the air liquefaction process.

    2.  Product is identified as Oxygen by way of oxygen specific paramagnetic analyzers

                    3.  Product is identified as oxygen through process validation, dedicated piping and product specific CGA fittings.

    Date/Time:         2017 10 10                          01:26                                                     OO/R-02-080/1-10

    Oxygen

  • PRINCIPAL DISPLAY PANEL

    PRAXAIR                              Track No:

    Haciendo nuestro planeta mds productive

    Certificate of Analysis (COA)

    PRAXAIR MEXICO S. de R.L. de C.V.

    700 Via Matamoros drive, Garza Cantu

    San Nicolas de los Garza, Nuevo Leon,

    64550 Mexico

    Oxygen USP NDA:                            210844                  Customer Name:             

    FDA Establishment Identifier:            3004658099           Praxair Number:              

    DUNS Number:                                 812821245

    LIQUID OXYGEN USP

    Batch Number:     _________

    Order:    ________               Lot Number:          __________                      Shipping Container:   ___________

    Component                        Specification                     Analytical ResultAnalytical Method1Analyzer Used

    Assay                                    NLT 99.5% by volume           _____%v/v                         Paramagnetic                    Servomex 4100

    Identification                         Positive                                _________                         Paramagnetic                    Servomex 4100

    Tester’s Signature:           __________________________

    Reviewer’s Signature:    _________________________

                                                    Quality Assurance Reviewer

    Notes:1.  Liquid oxygen produced by the air liquefaction process.

    2.  Product is identified as Oxygen by way of oxygen specific paramagnetic analyzers

                 3.  Product is identified as oxygen through process validation, dedicated piping and product specific CGA fittings.

    Date/Time:         _______________________                                                       OO/R-02-080/3-10

    Oxygen Label

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72223-002
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72223-002-0112310000 L in 1 CONTAINER; Type 0: Not a Combination Product06/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21084406/08/2017
    Labeler - Praxair Mexico, S. de R.L. de C.V (812953909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Praxair Mexico, S. de R.L. de C.V812953909manufacture(72223-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Praxair Mexico, S. de R.L. de C.V812821245manufacture(72223-002)

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