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510(k) Data Aggregation

    K Number
    K131410
    Device Name
    CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),
    Manufacturer
    SOUTHMEDIC, INC.
    Date Cleared
    2014-01-13

    (243 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUTHMEDIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to provide a means for sampling end tidal carbon dioxide with the option to deliver supplemental O2 therapy to patients for up to 24 hours.
    Device Description
    Southmedic's CO2/02 Nasal Cannula incorporates sampling nares that channel expired carbon dioxide to a capnograph. A port located between the two nares is used to deliver oxygen to the patient as needed from an oxygen source. Its unique design delivers 02 to both the nose and mouth area. This device when in use involves surface contact to the patient's intact skin. There is also gas pathway contact between patient and tubing/nasal cannula. Contact is considered limited exposure (up to 24 hours).
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    K Number
    K101953
    Device Name
    SMDIA-1000
    Manufacturer
    SOUTHMEDIC, INC.
    Date Cleared
    2011-01-07

    (179 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUTHMEDIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDIs. It is intended for use only when connected to ventilator tubing or tracheal tubes. The SMDIA-1000 MDI adaptor is single patient use, disposable.
    Device Description
    The Southmedic SMDIA-1000 is an adaptor which acts as an actuator for intermittent delivery of prescribed aerosol medications dispensed by meter dose inhalers (MDI). The SMDIA-1000 is connected to ventilator tubing and the MDI connected when drug delivery into the circuit is required. The SMDIA-1000 adaptor may also be connected to the endotracheal tube.
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    K Number
    K014211
    Device Name
    OXYARM CO2
    Manufacturer
    SOUTHMEDIC, INC.
    Date Cleared
    2002-06-11

    (172 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUTHMEDIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To deliver oxygen to patients in low to medium concentrations and provide a means to sample expired gases
    Device Description
    The Southmedic OxyArm CO2 is an oxygen delivery device with a headset and oxygen delivery port, which is placed in front of the patient vs. nasal cannula or over their mouth and nose. It also contains a port for taking a sample of expired gases, to measure exhaled end-tidal carbon dioxide. It is connected to a standard oxygen source and the sampling tubing to a standard end-tidal carbon dioxide monitor.
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