BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vivo 45 LS

    DI: 07321820061808 · Model: 006180 · Breas Medical AB
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vivo 45 LS
    Primary DI
    07321820061808
    Version / Model
    006180
    Catalog Number
    006180
    Company Name
    Breas Medical AB
    Labeler DUNS
    357007657
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-18
    Public Version
    1
    Public Version Date
    2022-06-27
    Public Version Status
    New
    Public Device Record Key
    08612f7f-7954-46c3-b1d4-fd4efd6d64dd

    Device Description

    PtcCO2 cable Radiometer

    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CBK Ventilator, Continuous, Facility Use
    NOU Continuous, Ventilator, Home Use

    GMDN Terms

    Code Name
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 07321820061808

    Customer Contacts

    Phone
    855-436-8724
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K193586 000