Label: NITROGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 52849-200-01, 52849-200-02 - Packager: Capweld Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated January 1, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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NITROGEN COMPRESSED LABEL
NITROGEN COMPRESSED NF UN 1066
CAUTION; HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION Store and use with adequate ventilation use equipment rated for cylinder pressure Close valve when not in use and when empty. Use in accordance with suppliers Material Safety Data Sheet.
FIRST AID: If inhaled, remove to fresh air. If not breathing, give
artificial respiration. If breathing is difficult, give oxygen. Call
a physician.
Do Not Remove this Product Label
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NITROGEN CERTIFICATE OF ANALYSIS
CUSTOMER ___________________ VENDOR / SUPPLIER ________________________ THIS LETTER IS TO PROVIDE YOU WITH THE
CERTIFICATION YOU REQUESTED FOR OXYGEN USP 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
Practices
(cGMP) Regulations.
CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST
CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84. THIS
CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY 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.
TEST REQUIREMENT NF SPECIFICATION LOT ANALYSIS
IDENTIFICATION PASS
ODOR PASS
Oxygen LESS THAT 1.0%
CARBON MONOXIDE LESS THAT 0.001%
ASSAY GREATER THAN 99.0%
The methodology being used to perform the USP / NF Test for
Assay is indicated below: Paramagnetic Analyzer Model # _________________________
Electrochemical Analyzer Model # _________________________
Gas Chromatography Official USP/NF method
Supplier Signature ____________________________ Date _______________________
J 700 a2 -
GENERAL WARNINGS AND PRECAUTIONS
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 hazards, contraindications, and
side effects and the precautions to be taken. Rx Only -
INGREDIENTS AND APPEARANCE
NITROGEN
nitrogen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52849-200 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52849-200-01 651 L in 1 CYLINDER 2 NDC:52849-200-02 5947 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1952 Labeler - Capweld Inc (033340977) Registrant - Capweld Inc (033340977) Establishment Name Address ID/FEI Business Operations Capweld Inc 033340977 manufacture