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510(k) Data Aggregation

    K Number
    K233965
    Device Name
    UltraDrape UGPIV Barrier and Securement (34-15)
    Manufacturer
    Parker Laboratories, Inc.
    Date Cleared
    2024-08-15

    (244 days)

    Product Code
    ITX, KGX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Parker Laboratories, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraDrape UGPIV Barrier and Securement, a sterile, single-use disposable device, serves as a sterile, viral barrier when used in conjunction with ultrasound transducers to shield patients from the potential transfer of contaminants and biological risk agents that may be introduced during ultrasound scanning and needle-quided procedures. It also serves as a transparent dressing to protect and secure devices to the patient's skin when required. UltraDrape UGPIV Barrier and Securement is indicated for adults and pediatric patients. For use by healthcare professionals appropriately trained in ultrasound within healthcare settings utilizing ultrasound.
    Device Description
    UltraDrape UGPIV Barrier and Securement is a uniquely designed, sterile, dual-action barrier and securement dressing designed for use during Ultrasound-Guided Peripheral Intravenous (UGPIV) procedures. UltraDrape is 3.25"(8.25 cm) wide x 5.8" (14.72 cm) long. UltraDrape UGPIV Barrier and Securement is sterile, nonirritating, non-sensitizing and is not made with natural rubber latex. Ultrasound imaging is not impaired by use of UltraDrape UGPIV Barrier and Securement as it is intended. The ultrasound gel is applied to a removable Polyurethane film layer to prevent contamination of the injection site. Convenient adhesive strips on the release film provide added securement of tubing and catheter hub surround. The bifurcated, "stand-alone" design prevents gel from reaching the IV site while enabling seamless catheter insertion and securement. UltraDrape UGPIV Barrier and Securement is furnished in sterile condition, for single use patient/procedure use, disposable. UltraDrape UGPIV Barrier and Securement is used with commercially available ultrasound probes.
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    K Number
    K953673
    Device Name
    ECLIPSE PROBE COVER
    Manufacturer
    PARKER LABORATORIES, INC.
    Date Cleared
    1996-03-14

    (220 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARKER LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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