BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AFFINITY®NT

    DI: 20613994375647 · Model: 95213 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    AFFINITY®NT
    Primary DI
    20613994375647
    Version / Model
    95213
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    4
    Public Version Date
    2020-01-22
    Public Version Status
    Update
    Public Device Record Key
    ccfc9b40-9cd3-494c-a635-cde3756b60fe

    Device Description

    OXYGENATOR 95213 AFFINITY 2PK 541R

    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 20613994375647
    Unit of Use 00613994375643

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K936003 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    – 50 Degrees Celsius