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510(k) Data Aggregation

    K Number
    K122885
    Device Name
    MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
    Manufacturer
    Date Cleared
    2013-08-29

    (343 days)

    Product Code
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISIZE BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEDISIZE GOLD Heater and Booster T-Piece is intended to feed additional heat and moisture into the system, through the T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.
    Device Description
    The reusable MEDISIZE GOLD Heater in combination with the disposable single use Medisize Gold Booster T-Piece (or Medisize Gold, 510k number K052615) combines the simplicity of a Heat and Moisture Exchanger (HME) with the features of active humidification. Use of the MEDISIZE GOLD Heater in combination with a HME increases the number of options for humidifying and heating respiratory gases, greatly expanding the field of application for HMEs. When used in combination with a HME, the MEDISIZE GOLD Heater improves the absolute humidity, the relative humidity and the temperature of the respiratory gases. Use of the MEDISIZE GOLD Heater makes it possible to administer additional moisture and heat in a simple way, which is self-regulating. As a result, use of the MEDISIZE GOLD Heater is not particularly labor or knowledge intensive. The ease of use makes it a reliable, stable and effective method to administer additional moisture and heat to patients when required.
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    K Number
    K081536
    Device Name
    MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
    Manufacturer
    Date Cleared
    2009-01-23

    (235 days)

    Product Code
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISIZE BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - The Medisize Red devices are breathing circuit bacterial filters, which are intended to remove microbiological and particulate matter from the gases in the breathing circuit. - These devices are intended to remove microbiological and particulate matter from the gases in the breathing circuit and at the same time the device in intended to be positioned over a trached to trached to the pollows during the-same into the using by passive means gases breathed in by patient dynng anaesthesia and ventilator care
    Device Description
    Bacterial/Viral filter and HME combination device
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    K Number
    K070714
    Device Name
    MEDISIZE GOLD HEATER AND BOOSTER
    Manufacturer
    Date Cleared
    2007-04-30

    (47 days)

    Product Code
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISIZE BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. The MEDISIZE GOLD Heater and Booster makes it possible to feed additional heat and moisture into the system, through a T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.
    Device Description
    Not Found
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    K Number
    K052615
    Device Name
    MEDISIZE GOLD
    Manufacturer
    Date Cleared
    2005-12-09

    (77 days)

    Product Code
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISIZE BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - 1. The Heat and Moisture Exchanger (HME) of the Medisize Gold is intended for passive humidification during anaesthesia and respiratory care. - 2. The integrated booster ability makes it possible to feed additional heat and moisture into the system during respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.
    Device Description
    Not Found
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