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    MEDIANA CO., LTD

    Manufacturer
    🇰🇷 South Korea·4 Importers

    MEDIANA CO., LTD.

    FDA registration
    MEDIANA CO., LTD.·13 products·🇰🇷 South Korea

    Mediana Co., Ltd. Body Composition Analyzer I20

    FDA UDI
    Mediana.CO.LTD·08800003455928·

    Mediana Co., Ltd. Body Composition Analyzer I30

    FDA UDI
    Mediana.CO.LTD·08800003471508·

    Mediana Co., Ltd. Body Composition Analyzer I30

    FDA UDI
    Mediana.CO.LTD·08800003455805·

    Mediana Co., Ltd. Body Composition Analyzer I50

    FDA UDI
    Mediana.CO.LTD·08800003467228·

    Mediana Co., Ltd. Body Composition Analyzer I35

    FDA UDI
    Mediana.CO.LTD·08800003466115·

    Mediana Co., Ltd. Body Composition Analyzer I25

    FDA UDI
    Mediana.CO.LTD·08800003458301·

    Mediana Co., Ltd. Body Composition Analyzer I50

    FDA UDI
    Mediana.CO.LTD·08800003466405·

    Mediana Co., Ltd. Body Composition Analyzer I55

    FDA UDI
    Mediana.CO.LTD·08800003466412·

    Mediana Co., Ltd. Body Composition Analyzer I25

    FDA UDI
    Mediana.CO.LTD·08800003468881·

    Mediana Co., Ltd. Body Composition Analyzer I55

    FDA UDI
    Mediana.CO.LTD·08800003467235·

    Mediana Co., Ltd. Body Composition Analyzer I35

    FDA UDI
    Mediana.CO.LTD·08800003458349·

    DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    FDA Enforcement
    Class II ·Terminated·Mediana Co., Ltd.·July 8, 2020

    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    FDA Enforcement
    Class II ·Terminated·Mediana Co., Ltd.·July 28, 2021

    NELLCOR

    FDA Adverse Event
    Malfunction ·MEDIANA CO. LTD.·Product code DQA·November 3, 2017

    NELLCOR

    FDA Adverse Event
    Malfunction ·MEDIANA CO. LTD.·Product code DQA·December 19, 2017

    NELLCOR

    FDA Adverse Event
    Malfunction ·MEDIANA CO. LTD·Product code DQA·December 21, 2017

    NELLCOR

    FDA Adverse Event
    Malfunction ·MEDIANA CO. LTD.·Product code DQA·October 3, 2017

    NELLCOR

    FDA Adverse Event
    Malfunction ·MEDIANA CO. LTD.·Product code DQA·June 25, 2021