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510(k) Data Aggregation

    K Number
    K191258
    Device Name
    Intraosseous infusion device
    Date Cleared
    2019-10-23

    (166 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Einstein Works, L.L.C

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIO-P for pediatric is intended to provide Intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients in age 3-12 years of age.
    Device Description
    The Einstein Works NIO Pediatric (NIO- P) Intraosseous Infusion Device permits intraosseous access through the Proximal Tibia and the Humeral Head. The NIO device is comprised of a trocar needle, spring, piston and housing and it resembles a syringe. When activated, a loaded spring is released, and the device injects the needle to a predetermined depth into the bone marrow cavity. The NIO device also features the same safety latch and trigger mechanism which is found with the predicate device.
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    K Number
    K182770
    Device Name
    Adult Intraosseous Infusion Device
    Date Cleared
    2019-04-09

    (193 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Einstein Works, L.L.C

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIO is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only. The NIO is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required, and intravenous access is not possible. The device is for use in adult patients only.
    Device Description
    The Adult NIO permits intraosseous access through the Proximal Tibia and the Humeral Head. The NIO device is comprised of a trocar needle, spring, piston and housing and it resembles a syringe. When activated, a loaded spring is released, and the device injects the needle to a predetermined depth into the bone marrow cavity.
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    Ask a specific question about this device

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