BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    1/2'' x 3/8'' x 3/8'' Y Connector w/L.L.

    DI: 36641670004353 · Model: 1.6 · Cardiomed Supplies Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    1/2'' x 3/8'' x 3/8'' Y Connector w/L.L.
    Primary DI
    36641670004353
    Version / Model
    1.6
    Catalog Number
    C-669
    Company Name
    Cardiomed Supplies Inc
    Labeler DUNS
    240623124
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2020-12-02
    Public Version
    1
    Public Version Date
    2020-12-10
    Public Version Status
    New
    Public Device Record Key
    2a2fe173-68c3-472c-b3e7-347deee53797

    Device Description

    This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.

    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
    Yes
    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
    Yes
    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
    63417 Low-pressure tubing connector, single-use, sterile

    Identifiers

    Type ID
    Unit of Use 16641670004342
    Primary 36641670004353

    Premarket Submissions

    Submission Number Supplement Number
    K833112 000