BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    REMOTE ASSISTANT™

    DI: 00681490199285 · Model: 9462 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    REMOTE ASSISTANT™
    Primary DI
    00681490199285
    Version / Model
    9462
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-23
    Public Version
    4
    Public Version Date
    2018-10-12
    Public Version Status
    Update
    Public Device Record Key
    f1b6c693-9416-4005-abbb-bdce74ecb498
    Distribution End Date
    2018-10-10

    Device Description

    SFTWR 9462 ACTVTR PATIENT REMOTE ASST

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXY implantable pacemaker Pulse-generator

    GMDN Terms

    Code Name
    31704 Cardiac pulse generator test magnet

    Identifiers

    Type ID
    Primary 00681490199285

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P970012 000