OXYGEN by Landauer Metropolitan, Inc / American Home Care Supply Midatlantic LLC / Miller Medical & Respiratory, Inc / American Home Care Supply New York LLC / Denmarks LLC / Genox Homecare LLC OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Landauer Metropolitan, Inc, American Home Care Supply Midatlantic LLC, Miller Medical & Respiratory, Inc, American Home Care Supply New York LLC, Denmarks LLC, Genox Homecare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP  CAS NO 7782-44-7 UN 1072 OXYGEN-2

PRODUCED BY AIR LIQUEFACTION.  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET  DO NOT REMOVE THIS PRODUCT LABEL

SIZE      CONTENT

M6         170 LITERS

ML6        170 LITERS

D            425 LITERS

E            680 LITERS

N            1736

OXYGEN REFRIGERATED LIQUID

OXYGEN REFRIGERATED LIQUID USP CAS NO 7782-44-7 UN 1073 OXYGEN-2

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  DO NOT REMOVE THIS PRODUCT LABEL CONTENTS AT 70 F AND 1 ATM WHEN FULL CONTENTS___________________________

FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.  USE IN ACCORDANCE WITH INSTRUCTIONAL LITERATURE.  FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN USP ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD DRUG AND COSMETIC ACT.

PRODUCT 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.

WARNING: HIGH PRESSURE OXIDIZING GAS WHICH VIGOROUSLY ACCELERATES COMBUSTION.  HANDLE AND STORE WITH CARE.  DO NOT DROP.  DO NOT USE OR STORE NEAR HEAT OR FLAME.  KEEP FREE FROM OIL AND GREASE.  USE ONLY WITH EQUIPMENT DESIGNED, CLEANED, AND RATED FOR USE WITH MEDICAL HIGH PRESSURE CYLINDER OXYGEN SYSTEMS.  OPEN VALVE SLOWLY.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER AN EXTENDED PERIOD OF TIME WITHOUT MONITORING ITS EFFECTS MAY BE HARMFUL.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING, UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.

LIQUID PRODUCT WARNINGS AND PRECAUTIONS

WARNING: EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.

DO NOT GET LIQUID IN EYES, ON SKIN, OR CLOTHING.  FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS). 

FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63289-001
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: 63289-001-01	170 L in 1 CYLINDER
2	NDC: 63289-001-02	248 L in 1 CYLINDER
3	NDC: 63289-001-03	120 L in 1 CYLINDER
4	NDC: 63289-001-04	400 L in 1 CYLINDER
5	NDC: 63289-001-05	670 L in 1 CYLINDER
6	NDC: 63289-001-06	900 L in 1 CYLINDER
7	NDC: 63289-001-07	3400 L in 1 CYLINDER
8	NDC: 63289-001-08	6800 L in 1 CYLINDER
9	NDC: 63289-001-09	8400 L in 1 CYLINDER
10	NDC: 63289-001-10	21 L in 1 DEWAR
11	NDC: 63289-001-11	31 L in 1 DEWAR
12	NDC: 63289-001-12	40 L in 1 DEWAR
13	NDC: 63289-001-13	45 L in 1 DEWAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1984

Labeler - Landauer Metropolitan, Inc (121561559)

Registrant - Landauer Metropolitan, Inc (121561559)

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		022933686	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		831777177	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		022150505	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		095370565	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		841338358	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		022933912	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		961574535	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Miller Medical & Respiratory, Inc		014761969	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply New York LLC		825888139	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Denmarks LLC		003468234	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		791285047	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		626129639	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
American Home Care Supply Midatlantic LLC		832743723	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Genox Homecare LLC		961576548	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Genox Homecare LLC		004119488	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Genox Homecare LLC		049163454	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Landauer Metropolitan, Inc		121561559	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Landauer Metropolitan, Inc		107641649	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Denmarks LLC		627341670	manufacture