BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CareLink SmartSync™ Percepta Serena Solara Application

    DI: 00763000002046 · Model: D00U004 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CareLink SmartSync™ Percepta Serena Solara Application
    Primary DI
    00763000002046
    Version / Model
    D00U004
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-13
    Public Version
    1
    Public Version Date
    2019-07-22
    Public Version Status
    New
    Public Device Record Key
    17e7aa59-ea67-4bed-80c4-86ce47eaf82f

    Device Description

    SW D00U004 SS PERCEPTA SERENA SOLERA

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    OSR Pacemaker/icd/crt non-implanted components

    GMDN Terms

    Code Name
    61680 Implantable cardiac device management application software

    Identifiers

    Type ID
    Primary 00763000002046

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P010015 399