Oxygen by NexAir, LLC / NEXAIR, LLC OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by NexAir, LLC, NEXAIR, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP UN1072
OXYGEN 2 OXYGEN PRODUCED BY AIR LIQUIFACTION Rx only.
DANGER: MAY CAUSE OR INTENCIFY FIRE; OXYDIZER. 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. WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical application, 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. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. Keep out of reach of children. DO NOT REMOVE THIS PRODUCT LABEL CAS: 7782-44-7
nexAir
Distributed by nexAir, LLC . www.nexAir.com
1385 Corporate Ave. . Memphis, TN 38132 . 888-639-2474
LOT #: PART #: CF. LITERS:

PRINCIPAL DISPLAY PANEL

REFRIGERATED LIQUID OXYGEN, REFRIGERATED LIQUID USP UN1073 CAS: 7782-44-7
NIET CONTENTS Part # C.F. Liters (Gaseous)
LQ OX-USP-GP55 5436 153,931
LQ O-USP-L1 4844 137,169
CO OX-DEWAR-20 912 25,810
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. Keep out of reach of children. Federal law requires that this container be filled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.
Produced by Air Liquiefaction.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXYDIZER. 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 sfe to do so. Use a back flow preventive device inthe 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 on or foll equipment over spills. Close valve after each use and when empty. Alway 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 advice/attention.
DO NOT REMOVE THIS PRODUCT LABEL.
Distributed by nexAir nexAir, LLC . www.nexAir.com
1385 Corporate Ave. . Memphis, TN 38132 . 888-639-2474

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 12213-720
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: 12213-720-59	170 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
2	NDC: 12213-720-62	255 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
3	NDC: 12213-720-13	408 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
4	NDC: 12213-720-53	566 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
5	NDC: 12213-720-58	663 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
6	NDC: 12213-720-43	30 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
7	NDC: 12213-720-44	31 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
8	NDC: 12213-720-15	1133 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
9	NDC: 12213-720-45	41 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
10	NDC: 12213-720-46	43 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
11	NDC: 12213-720-63	1699 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
12	NDC: 12213-720-50	2350 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
13	NDC: 12213-720-37	3511 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
14	NDC: 12213-720-17	4361 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
15	NDC: 12213-720-12	7051 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
16	NDC: 12213-720-16	2979 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
17	NDC: 12213-720-10	9543 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
18	NDC: 12213-720-67	127567 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
19	NDC: 12213-720-47	137167 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
20	NDC: 12213-720-48	153930 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205849	06/01/1996

Labeler - NexAir, LLC (927024422)

Establishment
Name	Address	ID/FEI	Business Operations
NEXAIR, LLC		063018874	manufacture(12213-720)

Establishment
Name	Address	ID/FEI	Business Operations
NEXAIR		105746421	manufacture(12213-720)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		106017541	manufacture(12213-720)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		192167567	manufacture(12213-720)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		603601050	manufacture(12213-720)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		609390711	manufacture(12213-720)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		927024422	manufacture(12213-720)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		969017086	manufacture(12213-720)