BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Home Monitoring Service Center

    DI: 04035479168773 · Model: 3.48 · BIOTRONIK SE & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Home Monitoring Service Center
    Primary DI
    04035479168773
    Version / Model
    3.48
    Catalog Number
    453795
    Company Name
    BIOTRONIK SE & Co. KG
    Labeler DUNS
    315620229
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-13
    Public Version
    2
    Public Version Date
    2020-10-19
    Public Version Status
    Update
    Public Device Record Key
    9caa1926-a927-4278-a0c4-cf64a5283499
    Distribution End Date
    2020-10-16

    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 04035479168773

    Customer Contacts

    Phone
    +1(888)345-0374
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P950037 197