BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Jewel Starter Kit

    DI: 00850047782038 · Model: ES-2 · Element Science, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Jewel Starter Kit
    Primary DI
    00850047782038
    Version / Model
    ES-2
    Catalog Number
    JWL1-STRT-K-01
    Company Name
    Element Science, Inc.
    Labeler DUNS
    079801768
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-12
    Public Version
    1
    Public Version Date
    2025-05-20
    Public Version Status
    New
    Public Device Record Key
    304ceb50-6792-4535-b0be-207b295c0803

    Device Description

    ES-2 Starter Kit, Finished, Packaged (Hair Trimmer, Placement Accessory, Adhesive Sheets, Patient Guide) (900-00036)

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MVK Wearable Automated External Defibrillator

    GMDN Terms

    Code Name
    48052 Wearable defibrillation system defibrillator

    Identifiers

    Type ID
    Primary 00850047782038