BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Manual Gel Bags

    Reg #: 1724474 · FEI: 3003094851 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Terumo BCT STERILIZATION SERVICES, Inc.
    Registration Number
    1724474
    FEI Number
    3003094851
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11308 W Collins Ave
    City
    LAKEWOOD
    State
    CO
    ZIP
    80215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K900585

    Owner / Operator

    Firm Name
    Terumo BCT, INC.
    Operator Number
    9002708
    Address
    10811 WEST COLLINS AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80215
    Country
    US
    Correspondent
    Corrine Lucas

    Products

    Device Name Product Code
    Set, I.V. Fluid Transfer LHI

    Proprietary Names

    Manual Gel Bags Tube Set Extension Piece Top Fill Bags 0.2 Micron Filter Attachment Vented Micro-Volume Inlet (MM12/23) Low Prime-Volume Fluid Transfer Tube Set Bag Adapter External-to Internal Thread Fluid Transfer Tube Set Fluid Transfer Tube Set with Vented Spike Luer Lock Universal Spike Gravity Mixing Set Bag Adapter Internal-to-External Thread

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)