BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TopCare health

    DI: 00036800464933 · Model: 036800464933 · TOPCO ASSOCIATES, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TopCare health
    Primary DI
    00036800464933
    Version / Model
    036800464933
    Company Name
    TOPCO ASSOCIATES, LLC
    Labeler DUNS
    072943876
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-30
    Public Version
    2
    Public Version Date
    2019-12-05
    Public Version Status
    Update
    Public Device Record Key
    807f2fc6-5e57-44a9-8c8c-1dc4950beab6

    Device Description

    3-Step Wound Care Kit, 40 items: 10 - Gauze Pad 4 IN x 4 IN (101 mm x 101 mm); 10 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 12 - Non-Stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 - Transparent Dressings 2.36 IN x 2.75 IN (59 mm x 69 mm); 3 - Rolled Gauze 4 IN x 2.5 YDS (101 mm x 2.28 m); 1 - Paper Tape 1 IN x 10 YDS (25 mm x 9.14 m)

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LRR First Aid Kit With Drug

    GMDN Terms

    Code Name
    44039 First aid kit, medicated

    Identifiers

    Type ID
    Package 10036800464930
    Primary 00036800464933