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510(k) Data Aggregation

    K Number
    K213948
    Device Name
    OxyMinder
    Manufacturer
    Bio-Med Devices, Inc.
    Date Cleared
    2022-03-17

    (90 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bio-Med Devices, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OxyMinder is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics.
    Device Description
    The OxyMinder is an air / oxygen blender mounted oxygen monitor capable of measuring the oxygen concentration from 18 to 100%. A Bio-Med specified oxygen sensor mounted to the blender outputs a voltage which is used by the OxyMinder to determine the concentration of oxygen. The OxyMinder calibrates at ambient air (21%) and 100% oxygen. The OxyMinder is software controlled. To measure the gas mixture of the blender the OxyMinder takes a sample of the gases to the sensor through a separate port and manifold which is separate from the gas pathway to the patient. This sample is then exhausted to the room. The OxyMinder sampling stream is not part of the gas pathway to the patient. The OxyMinder is used for continuous monitoring of the concentration of oxygen delivered to patients via air oxygen blenders. The monitor provides the following features: - Continuously displays the concentrated Oxygen level delivered to a patient. - Accepts user inputs via touch screen or button (power button). - Provides visual alarm messages, and audible alarms. - Displays the current alarm setting levels (High and Low O2 alarms). - Provides on-screen configuration tools such as O2 sensor calibration, touchscreen calibration, audio test, etc. - Monitors and displays the battery level and power source. - Ensures clean hospital airlines by automatically purging system periodically. The OxyMinder is designed to be mounted to a Bio-Med Devices air / oxygen blender via a manifold that houses the oxygen sensor and a solenoid. In addition to the primary function of monitoring oxygen concentration, the OxyMinder provides an automatic gas supply line purge function.
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    K Number
    K173973
    Device Name
    TV-100
    Manufacturer
    Bio-Med Devices, Inc.
    Date Cleared
    2018-07-20

    (203 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bio-Med Devices, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TV-100 is intended for use by qualified medical personnel to provide intermittent to continuous ventilatory support to neonatal, pediatric, and adult patients. The TV-100 is intended for use in both invasive and non-invasive ventilation modes. The TV-100 is intended for use in hospital including intrahospital transport, pre-hospital, and air transport settings.
    Device Description
    The TV-100 is designed to be a compact, lightweight, microprocessor controlled ventilator which allows for precise ventilatory control. The TV-100 features an internal compressor which allows the TV-100 to operate without the need for external pressurized gas supplies; however an external oxygen supply may be connected to blend with the air from the internal compressor. To further simplify use there are minimal ventilation controls. The TV-100 user interface (UI) is a touchscreen color LCD with full VGA resolution. The TV-100 ventilator is a DC powered device operating on internal lithium ion batteries and powered by an external IEC 60601-1 compliant power supply. The external supply also charges the batteries. Ventilation Modes include: A/C Mode (Assist/Control) CPAP Mode (Continuous Positive Airway Pressure) NIV Bilevel Mode (Non-invasive Ventilation) SIMV Mode (Synchronized Intermittent Mandatory Ventilation) PRVC Mode (Pressure Regulated Volume Control) Constant Flow Apnea Detection Standby Mode
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