BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INT,Force Inflation Device

    DI: 06950900920035 · Model: AI25 · Shanghai Kindly Medical Instruments Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INT,Force Inflation Device
    Primary DI
    06950900920035
    Version / Model
    AI25
    Company Name
    Shanghai Kindly Medical Instruments Co., Ltd.
    Labeler DUNS
    420827639
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-15
    Public Version
    1
    Public Version Date
    2023-08-23
    Public Version Status
    New
    Public Device Record Key
    613b8b4d-8ef4-44a7-bcba-f3612e062bd3

    Device Description

    20 ml, 30 atm, II, 500 psi OFF stopcock

    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
    No
    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
    MAV Syringe, Balloon Inflation

    GMDN Terms

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

    Identifiers

    Type ID
    Package 26950900920039
    Primary 06950900920035
    Package 46950900920033

    Premarket Submissions

    Submission Number Supplement Number
    K170027 000