BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ESU TRANSILLUMINATOR

    DI: 00860003720509 · Model: MK-02GX · ESU LIMITED LIABILITY PARTNERSHIP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ESU TRANSILLUMINATOR
    Primary DI
    00860003720509
    Version / Model
    MK-02GX
    Company Name
    ESU LIMITED LIABILITY PARTNERSHIP
    Labeler DUNS
    716244660
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-01
    Public Version
    2
    Public Version Date
    2023-08-03
    Public Version Status
    Update
    Public Device Record Key
    4b95d23f-716d-4e61-8527-6e06a703adf1

    Device Description

    The device supports the identification of veins in neonates and infants for venipuncture through the use of an LED that emits a wavelength close to the "optical window," allowing for deeper light penetration into human tissue.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HJN Transilluminator, Battery-Powered

    GMDN Terms

    Code Name
    48040 Infrared-light vein locator

    Identifiers

    Type ID
    Primary 00860003720509