BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Balloon Inflators

    DI: 06970057578422 · Model: VDK-IF-12 · Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Balloon Inflators
    Primary DI
    06970057578422
    Version / Model
    VDK-IF-12
    Company Name
    Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
    Labeler DUNS
    544430136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-20
    Public Version
    2
    Public Version Date
    2024-08-29
    Public Version Status
    Update
    Public Device Record Key
    0da53ecf-5b25-4632-8e07-5e09f73139d4

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PTM Syringe, Balloon Inflation, Exempt

    GMDN Terms

    Code Name
    17541 Catheter/overtube balloon inflator, single-use

    Identifiers

    Type ID
    Package 16970057578429
    Primary 06970057578422
    Package 56970057578427