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Dosage Form: gas

Oxygen COMPRESSED LABEL

Oxygen COMPRESSED USP  UN 1072    B15

A  AIR SOURCE INDUSTRIES, INC.
    3976 CHERRY AVE., LONG BEACH, CA 90807
    In (CA) (800) 295-4271  (562) 426-4017

Oxygen 2      AS - 2

WARNING: For emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation. For all other medical applications. Rx only. Uninterrupted use of high concentrations of Oxygen over a long duration, without monitoring its effect on Oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction.

DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS GAS UNDER PRESSURE. MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment cleaned for Oxygen service. Open valve slowly. 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.

CAS: 7782-44-7  DO NOT REMOVE TIS PRODUCT LABEL

Oxygen REFRIGERATED LIQUID LABEL

Oxygen, Refrigerated Liquid, USP

UN 1073 Rx ONLY

A AIR SOURCE INDUSTRIES, INC.
3976 CHERRY AVE., LONG BEACH, CA 90807
In (CA) (800) 295-4271 (562) 426-4017

Oxygen 2

D15   AS-16

Rx ONLY. WARNING: For emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation. For all other medical applications. Rx only. Uninterrupted use of high concentrations of Oxygen over a long duration, without monitoring its effect on Oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction.

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DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS REFRIGERATED GAS. MAY CAUSE CRYOGENIC BURNS OR INJURY: COMBUSTIBLES IN CONTACT WITH LIQUID Oxygen MAY EXPLODE ON IGNITION OR IMPACT. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for Oxygen service. Do not change or force fit connections. Avoid spills. Do not walk or roll equipment over spills. 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 ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advise/attention.

CAS: 7782-44-7 DO NOT REMOVE TIS PRODUCT LABEL

GENERAL WARNINGS AND PRECAUTIONS

Warning: for emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation.  For all other medical applications Rx Only.  Uninterrupted use of high concentrations of Oxygen over a long duration without monitoring Oxygen content of arterial blood may be harmful.  Uninterrupted use of high concentrations of Oxygen for more than 5 hours may be harmful.  Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.

keep oil and grease away

DO NOT REMOVE THIS PRODUCT LABEL

Caution:  Federal Law prohibits dispensing without prescription.  Rx Only

Oxygen 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           USP SPECIFICATION                  LOT ANALYSIS
IDENTIFICATION                         PASS
ODOR                                        PASS
CARBON DIOXIDE                    LESS THAT 0.03%
CARBON MONOXIDE                LESS THAT 0.001%
ASSAY                                     GREATER THAN 99.0%

*  NOTE: The USP/NF exempts facilities that manufacture Oxygen USP by the Air Liquefaction process from the tests for Carbon Dioxide and Carbon Monoxide.  
               As our label states, the Oxygen USP being supplied is manufactured by the Air Liquefaction Process.

The methodology being used to perform the USP / NF Test for
               Assay is indicated below:   Paramagnetic Analyzer    Model # _________________________
               J 700 a1

REVISION 1.0
               CERTIFICATE OF ANALYSIS - Oxygen USP

Oxygen 
0xygen gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10167-100
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxygen (Oxygen) Oxygen 99 L  in 100 L
Packaging
# Item Code Package Description
1 NDC:10167-100-01 420 L in 1 CYLINDER
2 NDC:10167-100-02 690 L in 1 CYLINDER
3 NDC:10167-100-03 113 L in 1 CYLINDER
4 NDC:10167-100-04 164 L in 1 CYLINDER
5 NDC:10167-100-05 139 L in 1 CYLINDER
6 NDC:10167-100-06 248 L in 1 CYLINDER
7 NDC:10167-100-07 647 L in 1 CYLINDER
8 NDC:10167-100-08 1724 L in 1 CYLINDER
9 NDC:10167-100-09 3160 L in 1 CYLINDER
10 NDC:10167-100-10 5270 L in 1 CYLINDER
11 NDC:10167-100-11 7060 L in 1 CYLINDER
12 NDC:10167-100-12 8510 L in 1 CYLINDER
13 NDC:10167-100-13 39560 L in 1 DEWAR
14 NDC:10167-100-14 197800 L in 1 DEWAR
15 NDC:10167-100-15 137600 L in 1 DEWAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205865 01/01/1992
Labeler - Air Source Industries Inc (969149129)
Registrant - Air Source Industries Inc (969149129)
Establishment
Name Address ID/FEI Operations
Air Source Industries Inc 969149129 manufacture(10167-100)
Revised: 06/2015
 
Air Source Industries Inc



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