BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    QUADROX-i

    DI: 04037691843346 · Model: Small Adult · Maquet Cardiopulmonary AG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QUADROX-i
    Primary DI
    04037691843346
    Version / Model
    Small Adult
    Catalog Number
    70105.5281
    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
    bcd7c631-ce3b-44f4-9c9b-178dee15e295
    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
    DTR HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
    DTZ OXYGENATOR, CARDIOPULMONARY BYPASS

    GMDN Terms

    Code Name
    17643 Extracorporeal membrane oxygenator

    Identifiers

    Type ID
    Package 04037691843353
    Primary 04037691843346

    Customer Contacts

    Phone
    +49072229320
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K132829 000