BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Balloon inflation device

    DI: 06971162819707 · Model: AT25ML · Tianck Medical Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Balloon inflation device
    Primary DI
    06971162819707
    Version / Model
    AT25ML
    Catalog Number
    103002
    Company Name
    Tianck Medical Co., Ltd.
    Labeler DUNS
    418642903
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-06
    Public Version
    2
    Public Version Date
    2023-05-18
    Public Version Status
    Update
    Public Device Record Key
    914e1099-8def-46e6-b126-532c64a5c9c2

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Primary 06971162819707
    Package 16971162819704
    Package 26971162819701