BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    QUADROX-i

    DI: 04037691913032 · Model: Adult, reservoir, filter · Maquet Cardiopulmonary AG
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QUADROX-i
    Primary DI
    04037691913032
    Version / Model
    Adult, reservoir, filter
    Catalog Number
    70106.4568
    Company Name
    Maquet Cardiopulmonary AG
    Labeler DUNS
    316153865
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-24
    Public Version
    6
    Public Version Date
    2020-02-03
    Public Version Status
    Update
    Public Device Record Key
    0153d114-4357-492c-85c9-20952f27a79e
    Distribution End Date
    2020-02-01

    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
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DTP Defoamer, cardiopulmonary bypass
    JOD FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS
    DTN RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

    GMDN Terms

    Code Name
    31710 Cardiotomy reservoir

    Identifiers

    Type ID
    Primary 04037691913032

    Customer Contacts

    Phone
    +49072229320
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K132166 000