BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Filter Platelets 6 RD w/Y Set - PL6YS

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K873667

    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
    Microfilter, Blood Transfusion CAK

    Proprietary Names

    Filter Platelets 6 RD w/Y Set - PL6YS Filter Platelets/APH w/Ext TBg - PXLAC Filter platelets 8 RD w/Y Set - PXL8Y Filter Platelets 12 RD w/TBG - PXL12C Filter platelets 8 RD w/S Set - PXL8K Filter Platelets PL3 w/ Tubing E - PL3VE Filter platelets 8 RD w/tbg - PXL8C Filter Platelets 6 RD s/S Set - PL6KS Filter Plasma Set - LPS2KLE Filter RC Polishing - PLUSRCT FILTER PLATELETS PL2 W/TBG E - PL2VE Filter Platelets 6 RD w/TBG - PL6T Filter Platelets PL3 w/Set E - PL3VAE Filter Platelet f/ 1 Unit w/TBG - PL1B Filter Platelets /APH w/ Y- Set - PXLAY Filter Platelets 12 RD w/S Set - PXL12K Filter Platelets 12 RD w/Y Set - PXL12Y Filter Plasma Leukoreduced w/ Tubing - LPS2 FILTER PL W/175 ML ALIQUOT - PL1BE FLT PL LEUKO LPS2 W/SET EU LB - LPS2KLE Filter Platelets PL2 w/Set E - PL2VAE Filter Plasma LPS2 w/TBG (EU) - LPS2E Filter Platelets /APH w/ S Set - PXLAK

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)