NITROGEN by Capweld Inc NITROGEN gas

NITROGEN by

Drug Labeling and Warnings

NITROGEN by is a Prescription medication manufactured, distributed, or labeled by Capweld Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 gas

Product 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