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510(k) Data Aggregation

    K Number
    K170900
    Device Name
    DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories
    Manufacturer
    INTERVENE Group Ltd
    Date Cleared
    2017-11-09

    (227 days)

    Product Code
    FMF, BSN, BSO, BSP
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERVENE Group Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DASH 6® NRFit Lock syringe and DASH® NRFit Slip Syringe are intended to be used with ISO 80369-6 NRFit neuraxial compliant devices for administration of neuraxial medication. The DASH 6® NRFit Plastic LOR Device is intended to be used with ISO 80369-6 NRFit neuraxial compliant epidural needle for locating the epidural space. Accessories: DASH 6® Introducer Needle is intended to be used with ISO 80369-6 NRFit neuraxial compliant spinal needle for guiding the placement of the spinal needle into the arachnoid/epidural space. DASH 6@ NRFit Syringe Cap is intended to be used with ISO 80369-6 NRFit neuraxial syringes for sealing the tip of the syringe. DASH 6® NRFit Drawing Up Filter Straw are intended to be used with ISO 80369-6 NRFit neuraxial syringe for the drawing up of neuraxial medication and anesthetic. DASH 6@ NRFit Blunt Drawing Up Needle (with and without filter) is intended to be used with ISO 80369-6 NRFit neuraxial syringe for the drawing up of neuraxial medication and anesthetic. DASH 6® NRFit Bacterial Disc Filter is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to ensure aseptic administration of neuraxial medication and anesthetic. DASH 6® NRFit Epidural Flat Filter is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to ensure aseptic administration of neuraxial medication and anesthetic. DASH 6® NRFit Tuohy-Borst Adapter is intended to be used with a epidural catheter to provide an ISO 80369-6 NRFit compliant connection. DASH 6® NRFit Syringe to Syringe Adapter is intended to be used with ISO 80369-6 NRFit neuraxial syringe to allow for mixing/transfering medication between two syringes. DASH 6® NRFit Needle Hub Cap is intended for sealing the hub of an NRFit compliant needle. DASH 6@ NRFit Epidural Catheter Feeder is intended to be used with ISO 80369-6 NRFit neuraxial compliant devices to assist the insertion of an epidural needle into the epidural space.
    Device Description
    The DASH 6® NRFit Syringes (Lock and Slip Syringes) are Single Use, in-hospital devices. They are provided in sizes ranging from 1 mL to 60 mL. The devices incorporate a male NRFit connector for connection to a female NRFit port. The syringes are designed according to ISO 7886-1 & ISO 80369-6 standard. The syringes are used for neuraxial purposes (ISO 80369-6 NRFit connection) and functions exactly the same as any hypodermic syringes that are on the market (ISO 7886-1). The syringes will be supplied as individually packed (sterile) and the bulk packed (Nonsterile). The Sterile packed items will be supplied directly to the user and the bulk packed will be supplied to Anesthetic Conduction Kit manufacturers to be packaged into kit. The syringe packaging will indicate the volume/size, the connector type (Lock or Slip variants) that the syringe contains and the sterility/sterilization method the syringe have been processed. The DASH 6 ° Plastic LOR devices are Single Use, in-hospital devices. It is provided with a 10 mL size/volume and incorporates a male ISO 80369-6 NRFit slip connector to connect to a female ISO 80369-6 NRFit Port. The Plastic LOR devices are designed according to ISO 80369-6 standard. The syringes are used for neuraxial purposes (ISO 80369-6 NRFit connection) and functions exactly the same as the LOR devices on the market. The device will be supplied as individually packed (sterile) and the bulk packed (Nonsterile). The Sterile packed items will be supplied directly to the user and the bulk packed will be supplied to Anesthetic Conduction Kit manufacturers to be packaged into kit. The devices packaging will indicate the volume/size, the connector type (Slip) that the device contains and the sterility/sterilization method the device have been processed. Accessories: DASH 6® NRFit Syringe Caps: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector. DASH 6® NRFit Drawing up Filter Straw: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and filter. DASH 6 ° NRFit Blunt Drawing up Needle (with and without filter): Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and blunt needle (with or without filter). DASH 6® NRFit Bacterial Disc Filter: Single Use, in-hospital devices with male & female ISO 80369-6 NRFit connectors and a 0.22µm filter. DASH 6® NRFit Epidural Flat Filter: Single Use, in-hospital devices with male & female ISO 80369-6 NRFit connectors and a 0.22um filter. DASH 6 ° NRFit Tuohy Borst Adapter: Single Use, in-hospital devices with a female ISO 80369-6 NRFit connector and open catheter port. DASH 6® NRFit Needle Hub Caps: Single Use, in-hospital devices with a Male ISO 80369-6 NRFit connector. DASH 6® Epidural Catheter Feeder: Single Use, in-hospital devices with a compatible male ISO 80369-6 NRFit connector.
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