FDA Label for Oxygen

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Oxygen Product Label

The following document was submitted to the FDA by the labeler of this product Praxair Mexico, S. De R.l. De C.v. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Oxygen



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


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