Nitrogen by Messer Gas Puerto Rico, Inc NITROGEN- nitrogen gas

Nitrogen by

Drug Labeling and Warnings

Nitrogen by is a Prescription medication manufactured, distributed, or labeled by Messer Gas Puerto Rico, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS SECTION

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

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

Messer
Gases for Life

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 (Messer 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% (Messer 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 Messer 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.”

2.5 January 2019

ASU-22-06-GAM-Medical Gas Procedures

Page 1 of 1

Retention Period – 3 Years

INGREDIENTS AND APPEARANCE

NITROGEN  
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52374-016
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Nitrogen (UNII: N762921K75) (Nitrogen - UNII:N762921K75)	Nitrogen	995 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52374-016-20	25000 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	NDA205816	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	api manufacture(52374-016) , manufacture(52374-016)