BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Affinity™ CP

    DI: 00613994647849 · Model: AP40 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Affinity™ CP
    Primary DI
    00613994647849
    Version / Model
    AP40
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-23
    Public Version
    5
    Public Version Date
    2020-05-19
    Public Version Status
    Update
    Public Device Record Key
    89156af5-5c5b-43f9-a1c1-0267bc787f5d

    Device Description

    PUMP AP40 AFFINITY CP CENTRIFUGAL NC

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KFM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

    GMDN Terms

    Code Name
    31718 Cardiopulmonary bypass system centrifugal pump

    Identifiers

    Type ID
    Package 20613994647843
    Primary 00613994647849

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K100631 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -30 – 50 Degrees Celsius