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  5. Label Information: Nitrogen

FDA Label for Nitrogen

View Indications, Usage & Precautions

Table of Contents

    1. NITROGEN COMPRESSED LABEL
    2. NITROGEN REFRIGERATED LIQUID LABEL
    3. NITROGEN CERTIFICATE OF ANALYSIS

Nitrogen Product Label

The following document was submitted to the FDA by the labeler of this product Indiana Oxygen Company 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.

Nitrogen Compressed Label



NITROGEN COMPRESSED NF UN1066 CAS 7727-37-9 Rx ONLY 39251 (03/05) INDIANA OXYGEN COMPANY 6099 W. CORPORATE WAY INDIANAPOLIS, IN 46278 317-290-0003 CONTENTS H=6400 LTR, OTHER _________________


Nitrogen Refrigerated Liquid Label



NITROGEN REFRIGERATED LIQUID NF UN 1977 NON-FLAMMABLE GAS 2 ALWAYS KEEP CONTAINER IN UPRIGHT POSITION DO NOT CHANGE OR FORCE FIT CONNECTIONS. Rx ONLY INDIANA OXYGEN COMPANY 6099 W. CORPORATE WAY INDIANAPOLIS, IN 46278 317-290-0003 43549 (05/05)


Nitrogen Certificate Of Analysis



Certificate of Analysis - Nitrogen NF Customer ________________________ Vendor / Supplier _____________________________ This letter is to provide you with the certification you requested for Nitrogen NF, Lot number ___________. supplied to you in cylinders / vessels by our location. These cylinders were filled in accordance with the standard operating procedures utilized for the manufacture of Medical Gases. By following these procedures, our location ensures that products are safely manufactured in compliance with FDA's Current Good Manufacturing Regulations. CAUTION: Vendor supplies this certification to customer to assist customer in ensuring compliance with 21 CFR 211.84. This certification does not eliminate customer's obligation to cmply with other portions of 21 CFR 210 and 211 including but not limited to 21 CFR 211.165 (finished product testing) for cylinders and vessels filled from these supply cylinders. These cylinders are not certified for instrument calibration purposes.

TEST/REQUIREMENT         NF SPECIFICATION             LOT ANALYSIS
IDENTIFICATION                    PASS
ODOR                                    NO APPRECIABLE ODOR
OXYGEN                               LESS THAN 1.0%
CARBON MONOXIDE             LESS THAN 10 PPM
ASSAY                                  GREATER THAN 99.0%

THE METHODOLOGY BEING USED TO PERFORM THE NF TEST FOR ASSAY IS INDICATED BELOW:

________________________ PARAMAGNETIC ANALYZER MODEL NUMBER ___________________

________________________ ELECTROCHEMICAL ANALYZER MODEL NUMBER ______________

_______________________ GAS CHROMATOGRAPHY OFFICIAL USP / NF METHOD

SUPPLIER SIGNATURE ___________________ DATE _________________

J 700 a1 (01/03) BR COMPLIANCE ASSOCIATES LLC


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