Oxygen by Praxair Mexico, S. de R.L. de C.V OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Praxair Mexico, S. de R.L. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80268-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80268-001-01	12310000 L in 1 CONTAINER; Type 0: Not a Combination Product	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA210844	08/01/2020

Labeler - Praxair Mexico, S. de R.L. de C.V (812505014)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Mexico, S. de R.L. de C.V		812505014	manufacture(80268-001)