FDA Label for Nitrogen

View Indications, Usage & Precautions

Nitrogen Product Label

The following document was submitted to the FDA by the labeler of this product Messer Canada Inc.. 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 And Precautions Section



Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”


Package Label.Principal Display Panel



 

Linde

Certicate of Analysis - Nitrogen NF

Product: Nitrogen NF

Date

 

Facility Name

 

Facility Address

 

Lot#

 

Batch #

 

Final Analysis Results

Analyzer #

Test/Units

NF Specs

Analysis Results

N/A

Odor

None

 

 

ppm O2

< 10,000

(Linde Spec <5.0)

  ppm

 

ppm CO

< 10.0

  ppm

 

ppm THC

N/A

  ppm

 

ppm H2O

N/A

  ppm

 

ppm CO2

N/A

  ppm

 

ppm H2

N/A

  ppm

Assay Results

Nitrogen min %

> 99.0%

(Linde Spec >99.999%)

%

NT= not tested

PPM O2 Method Used:             __________________________

Manufacturer/Model #:                  __________________________

PPM O2 Method Used:                         __________________________

Manufacturer/Model #:                               __________________________

This analyzer has been validated by Linde as acceptable alternatives to the official NF for Nitrogen Assay. Validation study documentation is maintained by Linde at the corporate offices.

Analyst

Date

 

 

 

 

Quality Reviewer

Date

 

 

 

 

 

Should the material not be delivered to a NF 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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