BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Heater-Cooler System

    DI: 04033817900511 · Model: 3T 208V ~ / 60Hz · LivaNova Deutschland GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Heater-Cooler System
    Primary DI
    04033817900511
    Version / Model
    3T 208V ~ / 60Hz
    Company Name
    LivaNova Deutschland GmbH
    Labeler DUNS
    343225272
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-14
    Public Version
    7
    Public Version Date
    2024-07-19
    Public Version Status
    Update
    Public Device Record Key
    18aa7a3b-bbfe-42a5-9318-237e9a0d994b

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DWC Controller, temperature, cardiopulmonary bypass

    GMDN Terms

    Code Name
    17206 Cardiopulmonary bypass system heating/cooling unit

    Identifiers

    Type ID
    Primary 04033817900511