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510(k) Data Aggregation

    K Number
    K970866
    Device Name
    FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
    Manufacturer
    GEORGIA BIOMEDICAL, INC.
    Date Cleared
    1998-01-23

    (319 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEORGIA BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Georgia BioMedical Filter Heater/Hydrator Insufflation Gas Conditioner is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.
    Device Description
    The Filter Heater/Hydrator Insufflation Gas Conditioner is a single use device which attaches to the outlet port of an insufflator and is designed to warm and humidify the gas stream prior to insufflation. The device consists of a universal gas connector, a control module which houses the control and safety circuits for the system and a disposable filter heater/humidifier (FHH) tubing set. Gas from the insufflator is routed into the FHH tubing set via the control module. Within the filter heater/humidifier tubing set particles >0.3 um in size are filtered from the gas, the gas is heated to 35°C and the gas is hydrated to >80% relative humidity. The distal end of the filter heater/humidifier tubing set terminates in a Luer lock connection for attachment to a gas entrance port for the abdomen, pleural space, chest cavity, abdominal cavity or any other body cavity.
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