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510(k) Data Aggregation

    K Number
    K031997
    Device Name
    MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
    Manufacturer
    MALLINCKRODT DAR S.R.L.
    Date Cleared
    2003-11-25

    (151 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT DAR S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This closed suction system is indicated for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.
    Device Description
    Ty-Care is a suction catheter system that is designed to connect to the endotracheal tube or tracheostomy tube of the patient and remains in place up to 48 hours ("fixed" version). Ty-Care exel is a detachable system and features a suction catheter that must be replaced after 24 hours while the angled connector (elbow) may be replaced after 72 hours of use. If the patient is on mechanical ventilation, this device allows the attending health professional to suction the patient's tracheobronchial secretions without disconnecting the ventilator. Ty-Care exel offers all the advantages of Ty-Care system with the added feature of a rotating patient-access valve.
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    K Number
    K993268
    Device Name
    MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
    Manufacturer
    MALLINCKRODT DAR S.R.L.
    Date Cleared
    2000-04-19

    (202 days)

    Product Code
    BTT, CAI
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT DAR S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility.
    Device Description
    The MALLINCKRODT DAR Heated Wire Breathing Circuit consists of the existing smooth bore breathing circuits (K942392, Airway Connectors with Flex Tube) into which a resistor has been molded into the inside of the external rib. Heating is controlled by ventilation/anesthesia breathing heaters or heater/humidifiers to which the MALLINCKRODT DAR Heated Wire Breathing Circuits are electrically connected. Some HWBC configurations may include traps for collection of the condensed moisture from patient exhalation or from humidification. Devices will be available in a variety of configurations.
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