BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACTIV.A.C.™

    DI: 00849554000285 · Model: 340000 · KCI USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACTIV.A.C.™
    Primary DI
    00849554000285
    Version / Model
    340000
    Company Name
    KCI USA, INC.
    Labeler DUNS
    102726734
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-01
    Public Version
    2
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    b1cb7be1-a19a-479e-992c-a9a53229a5a5

    Device Description

    Activac Therapy System

    Device Characteristics

    Single Use
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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
    47955 Negative-pressure wound therapy system, battery-powered, reusable

    Identifiers

    Type ID
    Direct Marking 00878237008188
    Primary 00849554000285

    Premarket Submissions

    Submission Number Supplement Number
    K063692 000