BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SELECT 3D® II

    DI: 20763000946863 · Model: 78420 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    SELECT 3D® II
    Primary DI
    20763000946863
    Version / Model
    78420
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2024-08-03
    Public Version
    1
    Public Version Date
    2024-08-12
    Public Version Status
    New
    Public Device Record Key
    ad22aaaf-9305-45b3-beee-c749dd1b2e9e

    Device Description

    CANNULA 78420 SELECT 3D II 20FR 20PK 17L

    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
    DWF Catheter, cannula and tubing, vascular, cardiopulmonary bypass

    GMDN Terms

    Code Name
    34893 Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

    Identifiers

    Type ID
    Unit of Use 00763000946869
    Primary 20763000946863

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K043179 000

    Device Sizes

    Type Value Unit Text
    Catheter Gauge 20.0 French