BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DVT-SERIES

    DI: 08809315675703 · Model: DS221 · DAESUNG MAREF CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DVT-SERIES
    Primary DI
    08809315675703
    Version / Model
    DS221
    Company Name
    DAESUNG MAREF CO.,LTD.
    Labeler DUNS
    688817949
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-21
    Public Version
    1
    Public Version Date
    2021-06-29
    Public Version Status
    New
    Public Device Record Key
    6daa0378-9299-4622-ad63-f66eae622b8b

    Device Description

    SOFT CALF SLEEVE Small 2ea, [One polybag]

    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
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JOW Sleeve, Limb, Compressible

    GMDN Terms

    Code Name
    44768 Multi-chamber venous compression system garment, reusable

    Identifiers

    Type ID
    Package 18809315675700
    Primary 08809315675703
    Package 28809315675707
    Package 38809315675704

    Premarket Submissions

    Submission Number Supplement Number
    K203016 000
    K203417 000