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510(k) Data Aggregation

    K Number
    K251592

    Validate with FDA (Live)

    Device Name
    SteriHub™ Disinfecting Device and Protective Cover
    Manufacturer
    1World Vista Medical
    Date Cleared
    2026-02-11

    (264 days)

    Product Code
    QBP
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K112791,K193190
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SteriHub™ Disinfecting Device and Protective Cover is intended for active disinfection of needleless connectors.

    The SteriHub Disinfecting Device and Protective Cover provides a physical barrier to contamination for up to 7 days, if not removed. The SteriHub may be used in the home or healthcare facility.

    Device Description

    The SteriHub™ Disinfecting Device and Protective Cover (SteriHub) is a single use disinfecting tool to be used on needleless connectors. The SteriHub, Model Number is SH-001, sterile cap contains 70% Isopropyl Alcohol (IPA) and disinfects the needleless connector via an active mechanical friction (scrub) while applying IPA. The SteriHub device also functions as a protective cover against contamination and recontamination of needleless connectors for up to 7 days.

    The device consists of HDPE housing that contains an element and core that are filled with 70% IPA. The device is sealed with a foil lid. Disinfection takes place by screwing the SteriHub onto connector, scrubbing by twisting back and forth ten (10) times, like juicing an orange. The combination of scrubbing and IPA application provides an active disinfection.

    AI/ML Overview

    N/A

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