BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Immugard WB Platelet Pooling Set

    Reg #: 1722028 · FEI: 1000117351 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Terumo BCT, Inc..
    Registration Number
    1722028
    FEI Number
    1000117351
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10811 W COLLINS AVE
    City
    Lakewood
    State
    CO
    ZIP
    80215
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK230838

    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
    Separator, Semi-Automated, Blood Component MYY

    Proprietary Names

    Immugard WB Platelet Pooling Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility