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510(k) Data Aggregation

    K Number
    K253964

    Validate with FDA (Live)

    Device Name
    Disposable Neonatal NIBP Cuff (U1681S-C51N)
    Manufacturer
    Unimed Medical Supplies, Inc.
    Date Cleared
    2026-01-09

    (29 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    0 - 0.08
    Reference & Predicate Devices
    K251045
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Unimed disposable blood pressure cuff (Models U1681S-C51N to U1685S-C51N) is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is non-sterile and for single-patient use. The cuff is available in neonatal sizes (3-15 cm limb circumference). The cuff is not designed, sold, or intended for use except as indicated.

    Device Description

    The Unimed Disposable Neonatal NIBP Cuff (Model U1681S-C51N) is a single-patient-use accessory for non-invasive blood pressure (NIBP) measurement. The cuff is designed for neonatal limb circumferences ranging from 3 cm to 6 cm. The cuff is intended to be used with compatible blood pressure monitors employing oscillometry. It is non-sterile, and is disposed of after single-patient use to reduce cross-contamination risks.

    AI/ML Overview

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