OXYGEN GAS [LANDAUER METROPOLITAN, INC]

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OXYGEN GAS [LANDAUER METROPOLITAN, INC]
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NDC 63289-001-01, 63289-001-02, 63289-001-03, 63289-001-04, 63289-001-05, 63289-001-06, 63289-001-07, 63289-001-08, 63289-001-09, 63289-001-10, 63289-001-11, 63289-001-12, 63289-001-13
Set ID 77259b35-5a93-42db-b03e-897e9a6d3d38
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Landauer Metropolitan, Inc
Generic Name
Product Class
Product Number
Application Number
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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.

  • INGREDIENTS AND APPEARANCE
    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
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