Oxygen by Messer LLC OXYGEN- oxygen gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Messer LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS 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

 

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 Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52438-011
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)	Oxygen	995 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52438-011-20	18144 L in 1 TANK; Type 0: Not a Combination Product	01/01/1960

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205767	01/01/1960

Labeler - Messer LLC (001368141)

Registrant - Messer LLC (001368141)

Establishment
Name	Address	ID/FEI	Business Operations
Messer LLC		943812438	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		026946218	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		041268947	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		101889988	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		003000197	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		081695020	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		872699181	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		002123321	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		066827916	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		092191712	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		839692303	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		791242337	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		192602431	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		945417111	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		042263707	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		147344667	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		102835006	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		940070527	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		969312248	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		004212362	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		019983468	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		079125660	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		079481211	manufacture(52438-011) , api manufacture(52438-011)

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Name	Address	ID/FEI	Business Operations
Messer LLC		809794592	manufacture(52438-011) , api manufacture(52438-011)

Establishment
Name	Address	ID/FEI	Business Operations
Messer LLC		108034669	manufacture(52438-011) , api manufacture(52438-011)