BEUDAMED
    FDA Registration Active 🇺🇸 United States

    800923-003 A2000V MULTIUSE SYRINGE KIT NEW WS and WI

    Reg #: 2022435 · FEI: 2022435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2022435
    FEI Number
    2022435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1401 Morgan Cir
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US

    Regulatory Submissions

    510(k) Number
    K984231

    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
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    800923-003 A2000V MULTIUSE SYRINGE KIT NEW WS and WI 800068-010 BT2000 Trigger No Hole AMT Manifold 800923-001 Assembly A2000V 800068-009 BT2000 Manifold Kit, West Plunger 5301 800061-008 A2000 Syringe Kit, New Braid Tube 800069-006 B2000 Manifold Kit, New Braid Tube 800068-016 BT2000 MANIFOLD KIT, QURE PLUNGER 800068-006 BT2000 Manifold Kit, New Braid Tube 800069-008 B2000 Trigger No Hole AMT Manifold 800923-002 ASSEMBLY A2000V 800061-014 A2000 LUERLESS MULTIUSE SYRINGE KIT NEW WS and WI 800068-008 BT2000 NHB Manifold 800068-007 BT2000 Manifold Kit, New Transducer 800061-016 A2000, CV2 Barrell 800068-011 BT2000 Alternative Material, Manifold Kit 800069-009 B2000 Alternative Material, Manifold Kit A2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold Kit

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)