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    K Number
    K033688
    Device Name
    MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    2004-05-19

    (177 days)

    Product Code
    NRH
    Regulation Number
    862.1820
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro H2 is a hand held hydrogen monitor used in the screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines. This increased level of hydrogen is expired and can be measured after ingestion of lactose following a period of fasting. Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician. Target Population: Adult, Child and Infant.
    Device Description
    The Micro H2 Breath Monitoring device is a battery operated hand held hydrogen breath monitor. Clinicians using this device have a patient expel their breath into an inlet port through a disposable mouthpiece adapter. The hydrogen concentration is then displayed in parts per million (ppm). The software utility, product name Hydra, will be supplied to purchasers of the breath hydrogen monitoring device. At the clinician's discretion, they can install Hydra on a Windows based PC. Thereafter, the handheld Micro H2 device can be connected to the PC via a serial communications cable to acquire and log successive breath hydrogen measurements during a diagnostic procedure.
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    K Number
    K991156
    Device Name
    GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
    Manufacturer
    GREAT SMOKIES DIAGNOSTIC LABORATORY
    Date Cleared
    1999-05-28

    (51 days)

    Product Code
    JOC
    Regulation Number
    862.1820
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Great Smokies lactulose/mannitol test for intestinal permeability is intended to measure the ratio of lactulose to mannitol in urine; the measurement is used in the diagnosis of gastrointestinal malabsorption syndrome.
    Device Description
    The device is a kit consisting of exempt components and accessories (urine specimen transport tubes (one white-capped "before drink" specimen tube and one purple-capped "after drink" specimen tube), a pipette, a small urine collection cup, a large urine collection container, a biohazard bag with absorbent pad, and a drink accessory (5g lactulose, 1g mannitol, 10g glycerine, and 3.84 ml water)). The drink is ingested after an overnight fast, and voided urine is then collected over a period of 6 hours to measure the level of lactulose and level of mannitol in urine and to obtain a ratio; the result is expressed as the percent recovery of an ingested dose of lactulose divided by the percent recovery of an ingested dose of mannitol. The measurement is used in the diagnosis of gastrointestinal malabsorption syndrome (a group of disorders in which there is abnormal absorption of dietary constituents, e.g., excessive absorption of substances or excessive loss from the body of nonabsorbed substances).
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    K Number
    K963376
    Device Name
    MICRO H2
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    1997-01-24

    (150 days)

    Product Code
    NRH
    Regulation Number
    862.1820
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    Matched: '862.1820'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Hs is a hand held hydrogen monitor, used in the screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines. This increased level of hydrogen is expired and can be measured after ingestion of lactose following a period of fasting.
    Device Description
    The Micro Hs is a hand held hydrogen monitor.
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