BEUDAMED
    Product Code: PJF FDA class 3

    Illuminator System For Blood Products

    Unknown

    The Illuminator System for Blood Products is a device used for the preparation and storage of pathogen-reduced blood components through photochemical illumination, intended to reduce the risk of transfusion-transmitted infections. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to the critical nature of blood product safety, reviewed by the Hematology (HE) panel. The product code is PJF, with no regulation number or medical specialty formally assigned. This device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PJF
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Preparation and storage of pathogen-reduced, blood components.

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.