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510(k) Data Aggregation

    K Number
    K140181
    Device Name
    MEDOS HILITE INFANT OXYGENATOR
    Manufacturer
    MEDOS MEDIZINTECHNIK AG
    Date Cleared
    2014-02-19

    (26 days)

    Product Code
    DTZ, DTR
    Regulation Number
    870.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDOS MEDIZINTECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 200 ml/min (0.2 liters/minute) to 1000ml/min (1.0 liters per minute) for the Hilite 1000 and 200 ml/min (0.2 liters/minute) to 800 ml/min (0.8 liters per minute) for the Hilite 800 LT for periods of up to six (6.0) hours.
    Device Description
    The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 infant hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 LT infant hollow fiber membrane consists of a polymetbylpentene plasma tight mat. The unique mat design increases tbe interaction between blood and gas, creating a highly efficient blood oxygenator. Tue heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through tbe inner lumen of the fibers and tberefore effects heat exchange while minimizing priming volume.
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    K Number
    K140177
    Device Name
    MEDOS HILITE OXYGENATOR
    Manufacturer
    MEDOS MEDIZINTECHNIK AG
    Date Cleared
    2014-02-18

    (25 days)

    Product Code
    DTZ, DTR
    Regulation Number
    870.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDOS MEDIZINTECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medos hilite 2800 & 2400 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 0.5 to 2.8 liters per minute for the hilite 2800 and 0.5 to 2.4 liters per minute for the hilite 2400 LT for periods of up to six (6.0) hours.
    Device Description
    The Medos Hilite 2800 & 2400 LT Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The Medos Hilite 2800 hollow fiber membrane consists of a polypropylene gas permeable mat. The Medos Hilite 2400 LT hollow fiber membrane consists of a polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to affect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The Medos Hilite 2800 and 2400 LT Oxygenators may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
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    K Number
    K133261
    Device Name
    MEDOS HILITE 7000 & 7000 LT OXYGENATOR
    Manufacturer
    MEDOS MEDIZINTECHNIK AG
    Date Cleared
    2014-01-09

    (78 days)

    Product Code
    DTZ
    Regulation Number
    870.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDOS MEDIZINTECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1 .0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.
    Device Description
    The MEDOS HI LITE 7000 & 7000 L T Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 LT hollow fiber membrane consists of a Polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifyigal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit,
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