Oxygen by Premier Medical Distribution OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Premier Medical Distribution. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal for Oxygen Product

OXYGEN

COMPRESSED

USP

UN 1072

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 of compatible materials of construction and rated for cylinder pressure. 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 NO: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

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.

OXYGEN,

REFRIGERATED

LIQUID USP

UN 1073

CONTENTS ________________LITERS

CAS NO: 7782-44-7

DANGER:

REFRIGERATED LIQUEFIED OXIDIZING GAS. ALWAYS

KEEP CONTAINER IN UPRIGHT POSITION. DO NOT

CHANGE OR FORCE FIT CONNECTIONS. 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 get in eyes, on skin, or on clothing. Keep reduction valves free

from grease and oil. In case of fire, stop leak if safe to do so. Avoid

spills. Do not walk or roll equipment over spills. Store and use in a well

ventilated place. Use only with equipment of compatible materials

of construction and rated for cylinder pressure. Wear cold insulating

gloves/face shield/eye protection. Protect from sunlight when ambient

temperature exceeds 52 F. Container temperature should

not exceed 52 F. Close valve after each use and when

empty. Use a back flow preventative device in the piping. Do not

handle until all safety precautions have been read and understood.

Use only with equipment cleaned for oxygen service. Keep/store away

from combustible materials. Do not drop. Use suitable hand truck for

container movement.

FIRST AID:

IN CASE OF FROSTBITE: Thaw frosted parts with lukewarm water.

Do not rub affected area. Get immediate medical advice/attention.

DO NOT REMOVE THIS PRODUCT LABEL.

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. Use only with pressure

reducing equipment and apparatus designed for oxygen. Do not

attempt to use on patients who have stopped breathing unless used in

conjunction with resuscitative equipment. Produced by Air Liquefaction.

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61520-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61520-001-01	415 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
2	NDC: 61520-001-02	248 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2009
3	NDC: 61520-001-03	165 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
4	NDC: 61520-001-04	682 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
5	NDC: 61520-001-05	60 L in 1 DEWAR; Type 0: Not a Combination Product	05/22/2007
6	NDC: 61520-001-06	47 L in 1 DEWAR; Type 0: Not a Combination Product	05/22/2007
7	NDC: 61520-001-07	6910 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
8	NDC: 61520-001-09	113 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
9	NDC: 61520-001-10	164 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
10	NDC: 61520-001-11	198 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
11	NDC: 61520-001-12	640 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
12	NDC: 61520-001-13	1738 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
13	NDC: 61520-001-14	3455 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		05/22/2007

Labeler - Premier Medical Distribution (015155753)

Registrant - Premier Medical Distribution (015155753)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Medical Distribution		015155753	manufacture(61520-001)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Medical Distribution		080319559	manufacture(61520-001)