BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WellSky Corporation. - Headquarters

    Reg #: 3006129391 · FEI: 3006129391 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    WellSky Corporation. - Headquarters
    Registration Number
    3006129391
    FEI Number
    3006129391
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11300 Switzer Road, --
    City
    Overland Park
    State
    KS
    ZIP
    66210
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK200479

    Owner / Operator

    Firm Name
    WellSky Corporation
    Operator Number
    9010846
    Address
    11300 Switzer Road, --
    City
    Overland Park
    State
    KS
    Postal Code
    66210
    Country
    US
    Correspondent
    David Y Stevens

    Products

    Device Name Product Code
    Blood Establishment Computer Software And Accessories MMH

    Proprietary Names

    WellSky Blood-Emergency Issue 2020 R1 WellSky Transfusion 2015R2 HCLL Transfusion 2015R2 LifeTrak2012 WellSky Transfusion 2022 R3 LifeTrak 2018 WellSky Blood Centers 2018

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device