BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PLEUR-EVAC

    Reg #: 3004111573 · FEI: 3004111573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3004111573
    FEI Number
    3004111573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1302 Avenue T
    City
    Grand Prairie
    State
    TX
    ZIP
    75050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K964070

    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
    Apparatus, Autotransfusion CAC

    Proprietary Names

    PLEUR-EVAC PE CONNECTOR 5MM X 10MM STR 20/BX PE SAHARA DRY SUC/SEAL LF W/ATS 3/BX PE PATIENT TUBING PLUG 20/BOX PE SAHARA DRY SUCT/DRY SEAL DUAL LF 6 PE SAHARA DRY SUCT/DRY SEAL LF 6/BX PATIENT DRAIN TUBE W/ Y CONN LF 6/BX PATIENT DRAINAGE TUBE LATEX 10/BX PE CONNECTOR 5 IN 1 20/BX PE CONNECTOR 3/8" "Y" 20/BX PE MINI SAHARA 6/BX LATEX FREE PE SAHARA DRY SUC/SEAL CONT REINF LF 6 PE CONNECTOR INFANT 20/BX PE SAHARA RAPID TRANSFER BAG 10/BX PE CONNECTOR 3/8" STRAIGHT 20/BX PE INFANT SAHARA DRY SUC/ SEAL LF 6/BX PE SAHARA ATS BAG LF 6/BX PE ATS BAG LF 6/BX

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)