BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EZLink-C

    DI: 00856298006435 · Model: EZLink-C · SCOTTCARE CORPORATION, THE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EZLink-C
    Primary DI
    00856298006435
    Version / Model
    EZLink-C
    Catalog Number
    103200
    Company Name
    SCOTTCARE CORPORATION, THE
    Labeler DUNS
    808204957
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-23
    Public Version
    1
    Public Version Date
    2024-05-31
    Public Version Status
    New
    Public Device Record Key
    4bf3c307-f344-425a-a921-b3bd6babb461

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

    GMDN Terms

    Code Name
    44098 Cardiology information system application software

    Identifiers

    Type ID
    Primary 00856298006435

    Customer Contacts

    Phone
    216-362-0550
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K020213 000