BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Centrifugal Pump 164275 Sarns Centrifugal Pump

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112229

    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
    Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type KFM

    Proprietary Names

    Centrifugal Pump 164275 Sarns Centrifugal Pump K112229 PUMP AFFINITY CP CENTRIFUGAL BC Bio-Pump® Centrifugal Pump with Carmeda® BioActive Surface Trillium Bio-Pump Plus PUMP AFFINITY CP CENTRIFUGAL CC Bio-Pump® Plus Centrifugal Blood Pump 164275 Sarns Centrifugal Pump CV-164275 Sarns Centrifugal Pump CV-164275X Sarns Centrifugal Pump Sarns Centrifugal Pump 164275X Sarns Centifugal Pump

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)