BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prevena Plus™

    DI: 00849554006768 · Model: PRE4000US · KCI USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prevena Plus™
    Primary DI
    00849554006768
    Version / Model
    PRE4000US
    Company Name
    KCI USA, INC.
    Labeler DUNS
    102726734
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-21
    Public Version
    5
    Public Version Date
    2021-11-23
    Public Version Status
    Update
    Public Device Record Key
    8002c8fc-16e9-42b5-8b05-714fa6eeb7d4

    Device Description

    Prevena Plus 125 Therapy Unit Prevena Plus 125 Therapy Unit with Prevena Plus 150ml Canister

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OMP Negative Pressure Wound Therapy Powered Suction Pump

    GMDN Terms

    Code Name
    58202 Negative-pressure wound therapy system, electric, single-use

    Identifiers

    Type ID
    Primary 00849554006768