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510(k) Data Aggregation

    K Number
    K193192
    Device Name
    Tamper Evident Cap
    Manufacturer
    International Medical Industries Inc.
    Date Cleared
    2020-01-31

    (73 days)

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

    International Medical Industries Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.
    Device Description
    The Tamper Evident Cap (TEC) is a sterile, single use device which will be used to cover male luer ports on medical devices and provide evidence of access. TEC is offered in multiple colors and all the components used in the device are comprised of polystyrene and polypropylene resin. The TEC device is marketed as a stand-alone device and packaged in bulk.
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    K Number
    K173577
    Device Name
    Guarded Luer Connector
    Manufacturer
    International Medical Industries Inc.
    Date Cleared
    2018-06-07

    (199 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    International Medical Industries Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guarded Luer Connector is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.
    Device Description
    The Guarded Luer Connector (GLC) is a polypropylene, sterile device, single use product intended to provide the fluid path for transferring large source container ingredients into smaller containers. The product is offered in two configurations; Female Luer lock (57-400) and Female-Male Luer Lock (57-401); both configurations meet the intended use. The Guarded Luer Connector is a connector for connecting two devices with fittings conforming to ISO 80369-7 for intravascular connectors and ISO 8536-10 for fluid line accessories.
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