FDA Label for Oxygen
View Indications, Usage & Precautions
Oxygen Product Label
The following document was submitted to the FDA by the labeler of this product Messer Llc. 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.
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
Linde
Certicate of Analysis - Oxygen USP
Product: Oxygen USP
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Final Analysis Results
Analyzer # | Test/Units | USP Specs | Analysis Results |
N/A | Odor | None |
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| % O2 | > 99.0% | % |
| 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 Linde as acceptable alternatives to the official USP for Oxygen Assay. Validation study documentation is maintained at the Linde Corporate Offices.
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Quality Reviewer | Date |
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Should the material not be delivered to a USP customer, the material is “Not Approved for Human Drug Use.”
2.4 October 2017
ASU-22-06-GAM-Medical Gas Procedures
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Retention Period – 3 Years
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