BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FILTER SYSTEM BPF4 RC W/BAG E

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    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
    BK910019

    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 SYSTEM BPF4 RC W/BAG E Filter BPF4 - BPF4BBS Filter System BPF4 RC NEO (G) - BPF4NEOG Filter RC BPF4 w/Bag & S Pouch - BPFB Filter Platelets/ APH 6 RD Set - LRFXLS RC BPF4 SC w/Storage Bag - S Pouch - 430-45 Filter System BPF4 for Neocyte (E) - BPF4NC Filter RC BPF4 w/Bag & S Pouch - BPFBLA FILTER RC BPFA W/BAG HK - BPFAPLUSHK RC BPF4 SC w/Storage Bag Pouch - 430-40 Filter Platelets/APH 6 RD SYS - LRFP Filter Platelets/APH 10 RD Set - LRF10S Blood Processing BPF4 Set (L) - BPF4BWL Filter Platelets/APH 4-10 RD S - 451-00 Filter Platelets/APH 6 RD Sets - 452-00 Filter RC BPF4 w/spike REC PRT - 400-00 Filter BPF4 w/Bag - BPF4BBSG RC BPF4 SC w/Storage Bag Pouch - 430-50 Filter Leukocyte System Latin - BPF4BBSL Filter Platelets/APH 6 RD SYS - LRF6BLA RD-HY Set - 490-00M Filter SYS BPF4 RC/AP w/Bag L - BPF4ARBL SC Set Assembly (BPF-4) W/Sample Pouch - 430-41 Filter System BPF4 RC/AP w/Bag B - BPF4ARBB Filter System BPFA RC w/BAG - BPFAPLUS Filter Platelets/APH 10 RD SYS - LRF10BLA Filter System BPF4 RC NEO (L) - BPF4NEOL Filter System BPF4 RC Hong Kong - BPF4BBSHK Filter BPF4 w/Spike Nordic - BPF4ARBN FILT SYS LEUKOBPF4RC/APW/BAGLL

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)