BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Blood Processing System Latin - ATSBC1PSL

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    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
    BK920023

    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
    Separator, Automated, Blood Cell, Diagnostic GKT

    Proprietary Names

    Blood Processing System Latin - ATSBC1PSL Filter System ATSBC PL Pool E - ATSBC Filter System LRP10 W/Bypass E - LRP10SE Filter System LRP10 W/2 CLX Bags F - LRP10SC2F Filter System LRPS PL w/ Bag L - LRP6BBSL Filter System ATSBC PL CLX-HP G - ATSBC1G Filter LRP6 w/BP & CLX Bag Ger - LRP6SCG Filter System LRP6 w/2 CLX Bag F - LRP6SC2F Filter System LRP10 PL w/Bag F - LRP10BBSF Filter System LRP6 PL W/Bag E - LRP6BBS Filter System LRP10 PLW/Bag G - LRP10BBSG Filter LRP10 w/ByPass Latin - LRP10BBSL Filter LPS1 Sterile System - LPS1B2U Filter System ATSBC PL CLX/S B - ATSBC1SB Filter LRPS Set w/Bypass - LRP6SE Filter System LRP6 w/2 CLX Bag G - LRP6SC2G Filter ATSBC Sterile Set UK - ATSBC1U Filter System LRP6 PL W/Bag F - LRP6BBSF Filter SYS ATSBC PL W/2 BAGS F - ATSBC2PSF LPS1 Sterile System - LPS1B1U Filter LRP6SCF w/BP & CLX Bag - LRP6SCF Filter System LRP10 PL w/Bag E - LRP10BBS Filter LRP6 Set w/BP & CLX Bag - LRP6SCL Filter SYS ATSBC PL POOL S B - ATSBCPSB Filter LPS1 Sterile System - LPS1B1N Filter System ATSBC PL CLX-HP/S U - ATSBC1SU Filter System Leuko LRP10 PL - LRP10BEL

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)