BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PCS 300, NexSys PCS

    Reg #: 3019849102 · FEI: 3019849102 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Haemonetics Corporation
    Registration Number
    3019849102
    FEI Number
    3019849102
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1300 Clifford Ball Drive
    City
    Clinton
    State
    PA
    ZIP
    15026
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK180185

    Owner / Operator

    Firm Name
    Haemonetics Corporation
    Operator Number
    1219343
    Address
    125 Summer St
    City
    Boston
    State
    MA
    Postal Code
    02110
    Country
    US
    Correspondent
    Julie A Ryan

    Products

    Device Name Product Code
    Separator, Automated, Blood Cell, Diagnostic GKT

    Proprietary Names

    PCS 300, NexSys PCS

    Establishment Types

    Manufacture Medical Device