Oxygen by GC Medical Equipment, Inc. OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by GC Medical Equipment, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP

UN1072

PRODUCED BY AIR LIQUEFACTION

WARNING:

For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, RX required. 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.

DANGER:

MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Obtain, read and follow all safety instructions before use. Keep away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use only with equipment of compatible materials of construction. Open valve slowly. Close valve after each use and when empty. Store and use with adequate ventilation. Protect from sunlight and physical damage. Always keep container in upright position. Use a backflow preventive device in the piping. Read and follow the Safety Data Sheet (SDS) before use.

CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

GC Medical Equipment Co., Inc.
4651 State Road
Peninsula, OH 44264
888-338-0202

NO SMOKING — NO VAPING

REFRIGERATED LIQUID

OXYGEN, REFRIGERATED LIQUID USP

UN1073

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.
DO NOT CHANGE OR FORCE FIT CONNECTIONS.

CONTENTS: _______ LTRS: _______ CU.FT.: _______

WARNING:

For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For other medical applications, RX required.

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 REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY.
COMBUSTIBLES IN CONTACT WITH OXIDIZING REFRIGERATED LIQUID MAY EXPLODE ON IGNITION OR IMPACT.

Obtain, read and follow all safety instructions before use. Keep away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use only outdoors or in well-ventilated area. Store and transport in upright position. Wear cold insulating gloves/face shield/eye protection. In case of fire: Stop leak if safe to do so. Use a backflow preventive device in the piping. Use only with equipment of compatible materials of construction and suitable for cryogenic service. Use only with equipment cleaned for oxygen service. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over hoses. 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 help.

CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

GC Medical Equipment Co., Inc.
4651 State Road
Peninsula, OH 44264
888-338-0202

NO SMOKING — NO VAPING

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66878-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	991 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66878-001-01	113 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
2	NDC: 66878-001-02	164 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
3	NDC: 66878-001-03	170 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
4	NDC: 66878-001-04	248 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
5	NDC: 66878-001-05	425 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
6	NDC: 66878-001-06	566 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
7	NDC: 66878-001-07	596 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
8	NDC: 66878-001-08	616 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
9	NDC: 66878-001-09	675 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
10	NDC: 66878-001-10	1699 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
11	NDC: 66878-001-11	3450 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
12	NDC: 66878-001-12	7106 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
13	NDC: 66878-001-13	9544 L in 1 CYLINDER; Type 0: Not a Combination Product	01/03/2011
14	NDC: 66878-001-14	28 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
15	NDC: 66878-001-15	40 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
16	NDC: 66878-001-16	55 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
17	NDC: 66878-001-18	180 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
18	NDC: 66878-001-19	41 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011
19	NDC: 66878-001-20	45 L in 1 DEWAR; Type 0: Not a Combination Product	01/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/03/2011

Labeler - GC Medical Equipment, Inc. (129946943)

Establishment
Name	Address	ID/FEI	Business Operations
GC Medical Equipment, Inc.		129946943	manufacture(66878-001)