Label: OXYGEN- oxygen gas
- NDC Code(s): 52374-011-20
- Packager: Messer Gas Puerto Rico, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 5, 2023
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- WARNINGS AND PRECAUTIONS SECTION
- SPL UNCLASSIFIED SECTION
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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.”
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52374-011 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:52374-011-20 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 NDA205818 01/01/1960 Labeler - Messer Gas Puerto Rico, Inc (090044413) Registrant - Messer Gas Puerto Rico, Inc (090044413) Establishment Name Address ID/FEI Business Operations Messer Gas Puerto Rico, Inc 833254548 manufacture(52374-011) , api manufacture(52374-011)