BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AccuRhythm™ AI

    DI: 00763000504519 · Model: ZA400 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AccuRhythm™ AI
    Primary DI
    00763000504519
    Version / Model
    ZA400
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-31
    Public Version
    1
    Public Version Date
    2022-01-10
    Public Version Status
    New
    Public Device Record Key
    b641cbf5-15e7-4764-aa68-064026d82368

    Device Description

    SW ZA400 ACCURHYTHM AI POST-PROCESSING

    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
    MXD Recorder, event, implantable cardiac, (with arrhythmia detection)

    GMDN Terms

    Code Name
    61680 Implantable cardiac device management application software

    Identifiers

    Type ID
    Primary 00763000504519

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K210484 000