OXYGEN GAS OXYGEN LIQUID [BAYCARE HOME CARE, INC.]

OXYGEN GAS OXYGEN LIQUID [BAYCARE HOME CARE, INC.]
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NDC 59400-001-01, 59400-001-02, 59400-001-03, 59400-001-04, 59400-005-01, 59400-005-02, 59400-005-03, 59400-005-04
Set ID 5e7deef4-d5c7-4133-aa2b-e31eeb9a6d7c
Category HUMAN PRESCRIPTION DRUG LABEL
Packager BayCare Home Care, Inc.
Generic Name
Product Class
Product Number
Application Number
  • Oxygen U.S.P.


    Oxygen Gas Label










    UN1072
    WARNING!
    High Pressure Oxidizing Gas Vigorously Accelerates Combustion

    Produced by Air Liquefaction

    Warning!
    For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.

    Caution: RX ONLY
    For other medical applications, use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours, 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. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with pressure reducing equipment and apparatus designed for oxygen service and rated for cylinder pressure. Open valve slowly before use. Close valve after each use and when empty.

    Federal law requires that this container be refilled with Gaseous Oxygen USP only by establishments registered as a Drug producer in accordance with the Federal Food, Drug and Cosmetic Act.

  • Refrigerated Liquid Oxygen U.S.P.

    Oxygen Liquid Label











    UN1073
    WARNING!

    High Pressure Oxidizing Liquid and Gas Under Pressure
    Vigorously Accelerates Combustion
    May Explode on Ignition or Impact
    Can Cause Severe Frostbite

    PRODUCED BY AIR LIQUEFACTION   

    Caution:  RX Only
    Warning!

    Keep oil, grease and combustibles away. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or clothing. For liquid withdrawal, wear face shield and gloves. Do not drop. Use hand truck for container movement. Avoid spills. Do not walk or roll equipment over spills. Close valve after each use and when empty.

    In case of frostbite, obtain medical treatment IMMEDIATELY.

    Keep out of reach of children. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with equipment and apparatus conditioned for oxygen service.

    Use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours 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 Liquid Oxygen USP only by establishments registered as a Drug Producer in accordance with the Federal Food, Drug and Cosmetic Act.

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59400-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen210 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59400-001-01670 L in 1 CYLINDER; Type 0: Not a Combination Product10/29/2013
    2NDC:59400-001-02425 L in 1 CYLINDER; Type 0: Not a Combination Product10/29/2013
    3NDC:59400-001-03140 L in 1 CYLINDER; Type 0: Not a Combination Product10/29/2013
    4NDC:59400-001-047760 L in 1 CYLINDER; Type 0: Not a Combination Product10/29/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas10/29/2013
    OXYGEN 
    oxygen liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59400-005
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen210 mg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59400-005-0134168 kg in 1 DEWAR; Type 0: Not a Combination Product11/05/2013
    2NDC:59400-005-0237585 kg in 1 DEWAR; Type 0: Not a Combination Product11/05/2013
    3NDC:59400-005-0325626 kg in 1 DEWAR; Type 0: Not a Combination Product11/05/2013
    4NDC:59400-005-0417084 kg in 1 DEWAR; Type 0: Not a Combination Product11/05/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas11/05/2013
    Labeler - BayCare Home Care, Inc. (794046607)
    Registrant - BayCare Home Care, Inc. (794046607)
    Establishment
    NameAddressID/FEIBusiness Operations
    BayCare Home Care, Inc.794046607manufacture(59400-001, 59400-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    BayCare Home Care, Inc.832097617manufacture(59400-001, 59400-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    BayCare Home Care, Inc.832097591manufacture(59400-001, 59400-005)

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