BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elite Medtek

    DI: 06939147402276 · Model: EM-ID-M14S · Elite Medtek (Jiangsu) Co., Ltd.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elite Medtek
    Primary DI
    06939147402276
    Version / Model
    EM-ID-M14S
    Company Name
    Elite Medtek (Jiangsu) Co., Ltd.
    Labeler DUNS
    542974341
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-19
    Public Version
    2
    Public Version Date
    2020-09-02
    Public Version Status
    Update
    Public Device Record Key
    812d7962-849e-4a96-b416-b13f16334d0a

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    GMDN Terms

    Code Name
    17541 Catheter/overtube balloon inflator, single-use

    Identifiers

    Type ID
    Primary 06939147402276
    Package 16939147402280
    Package 26939147402294