OXYGEN - oxygen gas 
Landauer Metropolitan, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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


HP OX 1

HP OX 2

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.


LIQUID LABEL 1


LIQUID LABEL 2

LIQUID LABEL 3

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.

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63289-001
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63289-001-01170 L in 1 CYLINDER
2NDC:63289-001-02248 L in 1 CYLINDER
3NDC:63289-001-03120 L in 1 CYLINDER
4NDC:63289-001-04400 L in 1 CYLINDER
5NDC:63289-001-05670 L in 1 CYLINDER
6NDC:63289-001-06900 L in 1 CYLINDER
7NDC:63289-001-073400 L in 1 CYLINDER
8NDC:63289-001-086800 L in 1 CYLINDER
9NDC:63289-001-098400 L in 1 CYLINDER
10NDC:63289-001-1021 L in 1 DEWAR
11NDC:63289-001-1131 L in 1 DEWAR
12NDC:63289-001-1240 L in 1 DEWAR
13NDC:63289-001-1345 L in 1 DEWAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1984
Labeler - Landauer Metropolitan, Inc (121561559)
Registrant - Landauer Metropolitan, Inc (121561559)
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC022933686manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC831777177manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC022150505manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC095370565manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC841338358manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC022933912manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC961574535manufacture
Establishment
NameAddressID/FEIBusiness Operations
Miller Medical & Respiratory, Inc014761969manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply New York LLC825888139manufacture
Establishment
NameAddressID/FEIBusiness Operations
Denmarks LLC003468234manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC791285047manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC626129639manufacture
Establishment
NameAddressID/FEIBusiness Operations
American Home Care Supply Midatlantic LLC832743723manufacture
Establishment
NameAddressID/FEIBusiness Operations
Genox Homecare LLC961576548manufacture
Establishment
NameAddressID/FEIBusiness Operations
Genox Homecare LLC004119488manufacture
Establishment
NameAddressID/FEIBusiness Operations
Genox Homecare LLC049163454manufacture
Establishment
NameAddressID/FEIBusiness Operations
Landauer Metropolitan, Inc121561559manufacture
Establishment
NameAddressID/FEIBusiness Operations
Landauer Metropolitan, Inc107641649manufacture
Establishment
NameAddressID/FEIBusiness Operations
Denmarks LLC627341670manufacture

Revised: 1/2010
Document Id: 3d49eb0a-d307-4ea9-a9c0-37319d56553b
Set id: 77259b35-5a93-42db-b03e-897e9a6d3d38
Version: 1
Effective Time: 20100101
 
Landauer Metropolitan, Inc