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 Badger Welding Supplies, 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 Nf Compressed Product Label
NITROGEN COMPRESSED NF
UN 1966
NON-FLAMMABLE GAS 2
37049 (1/15)
Rx only. WARNING:Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE SUFFOCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only withequipment rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. get medical advice/attention. CAS: 7727-37-9 DO NOT REMOVE THIS PRODUCT LABEL
BADGER WELDING SUPPLIES, INC.
101 SOUTH DICKINSON STREET • MADISON, WI 53703
608-257-5606
CONTENTS:
LTRS:
CU FT:
Refigerated Liquidnitrogen Refrigerated Liquid Nf Product Label
REFIGERATED LIQUID
NITROGEN REFRIGERATED LIQUID NF
UN1977
NON-FLAMMABLE GAS 2
Rx only.
WARNING: Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.
WARNING: CONTAINS REFIGERATED GAS: MAY CAUSE CRYOGENIC BURNS OR INJURY.
MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION
Do not handle until all safety precautions have been read and understood.
Use and store only outdoors or in a well-ventilated place.
Wear cold insulating gloves, face shield, and eye protection.
Use a back flow preventive device in the piping.
DO NOT change or force fit connections.
Close valve after each use and when empty.
Always keep container in upright position.
Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention
CAS: 7727-37-9
CONTENTS: ____________________________________________LTRS: _______________________________CU FT:
DO NOT REMOVE THIS PRODUCT LABEL
BADGER WELDING SUPPLIES, INC.
101 SOUTH DICKINSON STREET • MADISON, WI 53703
608-257-5606
43756 (04/17)
Nitrogen Nf Coa
Customer Vendor/Supplier
__________________ ________________________
__________________ ________________________
__________________ ________________________
This letter is to provide you with the certificatio you requested for Nitrogen NF, Lot # __________________
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 Practices (cGMP) Regulations and FDA Medical Gas Guidlines.
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 comply with other portions of 21 CFR 210 & 211 including but not limited to 21 CFR 211.265 (finished product testing) for cylinders and vessels filled from these supply cylinders. These cylinders are not certified for instrument calibration purposes.
Test / Requirement | NF Specifications | Lot Analysis |
Identification | Pass | |
Odor | No appreciable odor | |
Oxygen | ≤ 1.0% | |
Carbon Monoxide | ≤ 10 ppm | |
Assay | ≥ 99.0% |
The methodology being used to perform the NF Test for Assay is indicated below:
_________________ Pramagnetic Analyzer Model # ________________
_________________ Electrochemical Analyzer Model # ________________
These analyzers have been validated as acceptable alternatives to the official NF Gas Chromatography method for Nitrogen Assay. Validation study documentation is available.
________________ Gas Chromatogrphy
Official USP / NF method.
Supplier Signature_________________________________ Date _________________
YHIS DOCUMENT CONTAINS CONFIDENTIAL OR PROPRIETARY INFORMATION OF LINDE, INC. AND/OR LINDE GAS NORTH AMERICA LLC. NEITHER THE DOCUMENT NOR THE INFORMATION THEREIN IS TO BE REPRODUCED, DISTRIBUTED, USED OR DISCLOSED, EITHER IN WHOLE OR IN PART EXCEPT AS SPECIFICALLY AUTHORIZED BY LINDE, INC. AND /OR LINDE GAS NORTH AMERICA LLC.
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