BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Angioway

    DI: 06936733735886 · Model: LP-P-30 · Lepu Medical Technology (Beijing) Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Angioway
    Primary DI
    06936733735886
    Version / Model
    LP-P-30
    Company Name
    Lepu Medical Technology (Beijing) Co.,Ltd.
    Labeler DUNS
    529853921
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-23
    Public Version
    3
    Public Version Date
    2020-05-06
    Public Version Status
    Update
    Public Device Record Key
    4acc87f2-f49b-4138-b5fd-6591617695fc

    Device Description

    The inflation device is applied to inflate/deflate balloon catheters and monitor pressure within the balloon.

    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
    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
    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 16936733735883
    Primary 06936733735886