BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Carpentier Bi-Caval Femoral Cannula

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1319639
    FEI Number
    1000138054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 Park Rd
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032041

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    Carpentier Bi-Caval Femoral Cannula DLP® Aortic Root Cannula with Vent Line Signature¿ Sterile Class VI Tubing Bio-Medicus® Femoral Venous Cannula EOPA CAP¿ Arterial Cannula Gentle Vent Pump Header DLP® Venous Cannula MC2X¿ Three Stage Venous Cannula CANNULA EOPA 3D DLP® Aortic Root Cannula Bio-Medicus® One-Pc. Femoral Arterial Cannula Pediatric Aortic Root Cannula SELECT Series® Arterial Cannula DLP® Heart Tray DLP® Vent Catheter DLP® Arterial Cannula DLP® Pressure Catheter Placement Set Ultraflex¿ Venous Cannula MULTI STAGE VENOUS CANNULA SELECT 3D® Arterial Cannula EOPA¿ Arterial Cannula DLP® Malleable Single Stage Venous Cannula DLP® Pericardial Sump Distal Perfusion Catheters CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Distal Perfusion Catheters K032041

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)