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510(k) Data Aggregation

    K Number
    K090738
    Device Name
    THERMOFLO HCH, THERMOFLO FILTER
    Manufacturer
    ARC MEDICAL, INC.
    Date Cleared
    2009-07-27

    (129 days)

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

    ARC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FilterFlo™ filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anesthetic or ventilator breathing systems. The FilterFlo™ filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas conveying parts of the ventilator. The ThermoFlo™ filter/HME is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The product is the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since heated humidified are almost impossible to use. The ThermoFlo™ filter/HME should be used with patients who have a Tidal Volume between 250 - 1500 ml. The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours.
    Device Description
    The ARC Medical filter and filter / HME are standard breathing circuit filters or filter / HMEs.
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    K Number
    K063125
    Device Name
    FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)
    Manufacturer
    ARC MEDICAL, INC.
    Date Cleared
    2007-04-13

    (182 days)

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

    ARC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011212
    Device Name
    FILTERFLO H
    Manufacturer
    ARC MEDICAL, INC.
    Date Cleared
    2001-12-20

    (244 days)

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

    ARC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982239
    Device Name
    CIRCUIT GUARD
    Manufacturer
    ARC MEDICAL, INC.
    Date Cleared
    1998-08-14

    (52 days)

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

    ARC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.
    Device Description
    The Circuit Guard is a thin-wall sleeve which when attached to a Filter / HME housing, is pulled over the breathing circuit wye and tubing to cover these items to reduce gross contamination of the circuit components. It is viewed to be similar the intended use of a sleeved suction catheter. This is a modification of our ARC Filter and ARC Filter / HME.
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