Oxygen
FDA Label NDC 80268-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Praxair Mexico, S. De R.l. De C.v for the product Oxygen (NDC 80268-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding oxygen, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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