BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ACTIV.A.C.™

    DI: 00849554001992 · Model: M8275058/5 M8275058/10 · KCI USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACTIV.A.C.™
    Primary DI
    00849554001992
    Version / Model
    M8275058/5 M8275058/10
    Company Name
    KCI USA, INC.
    Labeler DUNS
    102726734
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-05
    Public Version
    5
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    a1e29831-94ed-48de-ac1c-add7b26844f8

    Device Description

    300 ml Canister (with Gel) for Activac Therapy System Fluid Path Sterile

    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
    Labeling does not contain MRI Safety Information
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OMP Negative Pressure Wound Therapy Powered Suction Pump

    GMDN Terms

    Code Name
    47404 Negative-pressure wound therapy system canister

    Identifiers

    Type ID
    Primary 00849554001992
    Package 00849554000940
    Package 00849554000957

    Premarket Submissions

    Submission Number Supplement Number
    K063692 000