BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TRILLIUM™ AFFINITY®NT

    DI: 00721902648755 · Model: 95249 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TRILLIUM™ AFFINITY®NT
    Primary DI
    00721902648755
    Version / Model
    95249
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-24
    Public Version
    4
    Public Version Date
    2020-01-22
    Public Version Status
    Update
    Public Device Record Key
    95273909-c795-41e7-872b-326dd80ac9d5

    Device Description

    RESERVOIR 95249 AFFINITY 4CA CVR-T 540T

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DTN RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

    GMDN Terms

    Code Name
    17643 Extracorporeal membrane oxygenator

    Identifiers

    Type ID
    Package 20721902648759
    Primary 00721902648755

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K021287 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 50 Degrees Celsius