BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir

    DI: 00699753450134 · Model: 3CX*RX15RE30 · Terumo Cardiovascular Systems Corporation
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir
    Primary DI
    00699753450134
    Version / Model
    3CX*RX15RE30
    Company Name
    Terumo Cardiovascular Systems Corporation
    Labeler DUNS
    177655466
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-01
    Public Version
    4
    Public Version Date
    2020-01-22
    Public Version Status
    Update
    Public Device Record Key
    908d3511-76e7-4627-83ab-f0035d8d3af6

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DTZ Oxygenator, Cardiopulmonary Bypass
    DTN Reservoir, Blood, Cardiopulmonary Bypass
    DTR Heat-Exchanger, Cardiopulmonary Bypass
    DTP Defoamer, Cardiopulmonary Bypass

    GMDN Terms

    Code Name
    17643 Extracorporeal membrane oxygenator

    Identifiers

    Type ID
    Package 50699753450139
    Primary 00699753450134

    Premarket Submissions

    Submission Number Supplement Number
    K130333 000
    K153213 000