BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CareLink SmartSync™ Azure Astra Application

    DI: 00763000002039 · Model: D00U003 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CareLink SmartSync™ Azure Astra Application
    Primary DI
    00763000002039
    Version / Model
    D00U003
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-06
    Public Version
    2
    Public Version Date
    2019-07-02
    Public Version Status
    Update
    Public Device Record Key
    7797dacb-23d2-44fe-989a-2d437c3d9e65

    Device Description

    SW D00U003 SS AZURE ASTRA

    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
    DTC ANALYZER, PACEMAKER GENERATOR FUNCTION
    DTA TESTER, PACEMAKER ELECTRODE FUNCTION

    GMDN Terms

    Code Name
    61680 Implantable cardiac device management application software

    Identifiers

    Type ID
    Primary 00763000002039

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P980035 536
    P980035 583