BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BioMonitor

    DI: 04035479135539 · Model: 2-S · BIOTRONIK SE & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioMonitor
    Primary DI
    04035479135539
    Version / Model
    2-S
    Catalog Number
    398494
    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
    2016-04-29
    Public Version
    6
    Public Version Date
    2021-08-30
    Public Version Status
    Update
    Public Device Record Key
    97a69ae3-6b36-4d41-8de4-ec77ee9abbf3
    Distribution End Date
    2021-08-27

    Device Characteristics

    Single Use
    Yes
    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MXD RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)

    GMDN Terms

    Code Name
    47804 Implantable cardiac monitor

    Identifiers

    Type ID
    Primary 04035479135539

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K152995 000