Label: NITROGEN- nitrogen gas
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- NDC Code(s): 52374-016-20
- Packager: Messer Gas Puerto Rico, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 11, 2022
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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 - 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
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INGREDIENTS AND APPEARANCE
NITROGEN
nitrogen gasProduct 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)