BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prevena Restor Adapti-Form Dressing PRE6055

    Reg #: 3005178245 · FEI: 3005178245 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    KCI USA, INC.
    Registration Number
    3005178245
    FEI Number
    3005178245
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6203 FARINON DR.
    City
    SAN ANTONIO
    State
    TX
    ZIP
    78249
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220660

    Owner / Operator

    Firm Name
    3M COMPANY
    Operator Number
    2110898
    Address
    3M Center, 2510 Conway Avenue, Bldg. 275-5W-06
    City
    Saint Paul
    State
    MN
    Postal Code
    55144
    Country
    US
    Correspondent
    JEFFERY J SCHORR

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Device For Reduction Of Wound Complications QFC
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    Prevena Restor Adapti-Form Dressing PRE6055 Prevena Restor Adapti Form Incision Management System PRE6001

    Establishment Types

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