BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affinity Fusion®

    DI: 00643169354869 · Model: BB841 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Affinity Fusion®
    Primary DI
    00643169354869
    Version / Model
    BB841
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-02
    Public Version
    4
    Public Version Date
    2020-01-22
    Public Version Status
    Update
    Public Device Record Key
    bb7cdcb2-9604-4ef7-acd1-ba70f0014e39

    Device Description

    OXY/CVR COMBO BB841 FUSION W/BALANCE

    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
    Primary 00643169354869

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K132972 000

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    30 – 75 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -30 – 50 Degrees Celsius