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510(k) Data Aggregation

    K Number
    K172719
    Device Name
    HealthBeacon HB2 Sharps Bin
    Manufacturer
    Date Cleared
    2018-05-11

    (245 days)

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

    HealthBeacon Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HealthBeacon HB2 Sharps Bin is intended for use by a single patient in the home setting. The HealthBeacon HB2 Sharps Bin comprises an outer enclosure that remains in the home. The outer enclosure contains a replaceable, single-use sharps bin that is intended to provide a receptacle for used, contaminated medical sharps. The single-use sharps bin also acts as an enclosure during transport of the used sharps to ultimate disposal.
    Device Description
    The HealthBeacon HB2 Sharps Bin device is the combination of the: - . Outer Enclosure, which remains in the home, and - The single use Inner Sharps Bin, which is disposed of, once full. . The HealthBeacon HB2 Sharps Bin comprises: - A custom-shaped sharps bin molded in puncture-resistant polypropylene . plastic. - . An integral sliding and permanently locking lid to close over after use and prior to dispatch to the destruction facility. - A custom enclosure (the "HealthBeacon HB2 enclosure") for the sharps bin. ● The HealthBeacon HB2 Enclosure provides: - o A neutral and attractive cover for the sharps bin whilst it is being used in a domestic environment. - o A double trap door access path to the sharps bin to prevent fingeraccess to the sharps bin and its contents of used syringes while in the Enclosure with the side door closed. - o A counter of syringes being deposited that will give the user a warning when the sharps bin is getting close to full. The HealthBeacon HB2 Sharps Bin is molded from 2mm (0.08 inch) polypropylene in 3 snap-together sections. The sharps bin door is a sliding door that once fully closed, locks and cannot be re-opened. The HealthBeacon HB2 Enclosure is a neutrally colored enclosure for the sharps bin. The enclosure is molded from ABS plastic and has interlocks so that the sharps bin can only be fitted in the correct orientation within the enclosure. The enclosure door flap lines up with the sharps bin opening, and there is a spring-loaded trap-door within the enclosure that prevents direct access into the sharps bin itself. The HealthBeacon HB2 Enclosure has a small electronics module to count and record the used hypodermic syringes being deposited. The usage information is passed to a cloud-based tracking database to provide compliance information. The tracking database also provides prompts to the user on a display screen in the HealthBeacon HB2 Enclosure. The prompts inform the user when the next selfadministered injection is due and the injection site to be used, so that they are rotated in time and thus lower the chance of adverse reactions. The patient can also elect to have text message reminders sent their cell phone. The HealthBeacon HB2 Enclosure is powered by a Medical Device Certified (to IEC60601-1) power supply. This supplies electrical power for the small electronic counter unit.
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