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510(k) Data Aggregation

    K Number
    K170371
    Device Name
    DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe
    Manufacturer
    INTERVENE Group Limited
    Date Cleared
    2017-10-20

    (256 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERVENE Group Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DASH 3TM ENFit Syringe is a sugle use syninge indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nututional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral synnges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups. The DASH 3TM Eccentric ENFit Syringe is a single use syringe indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups. The DASH 3TM Low Volume Tip ENFit Syringe is a sungle use syringe indicated for use as a dispenser, a measuning device, and a fluid transfer device. It is used to deliver fluids or nutritional formula into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syninges are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinicians, in all age groups. The DASH 3M ENFit Syringe Cap allows the advance preparation and secure storage and transport of medication fluids or mutritional formula. The synnge cap will fit any size of the Single Use Synnges (DASH 3TM)
    Device Description
    The DASH 3™ ENFit Syringe device family is a Single Use, in-hospital and home care (DASH 3TM ENFit Syringe, DASH 3TM Eccentric ENFit Syringe, DASH 3TM ENFit Low Dose Tip Syringe) device. It is provided in sizes from 1 mL to 100 mL. The device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit port specified in ISO 80369-3. The Low Dose Tip contains the low dose design feature specified in (Draft) ISO 20695. The DASH 3TM ENFit accessories are designed to be compatible with ENFit connector devices. The DASH 3TM ENFit Syringe Caps fit any size of the Single Use ENFit Syringes (DASH 3™), which allows the advance preparation and secure storage and transport of medication/fluids or nutritional formula.
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