BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter

    DI: 00627825013550 · Model: CATEB37C · Laborie Medical Technologies Corp.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter
    Primary DI
    00627825013550
    Version / Model
    CATEB37C
    Company Name
    Laborie Medical Technologies Corp.
    Labeler DUNS
    117783313
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-12
    Public Version
    1
    Public Version Date
    2024-12-20
    Public Version Status
    New
    Public Device Record Key
    f689ff4e-12f1-45c6-a97e-9eb9aae9cbdc

    Device Description

    e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter

    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
    FEN Device, Cystometric, Hydraulic

    GMDN Terms

    Code Name
    62243 Urodynamic manometric catheter, electronic, single-use

    Identifiers

    Type ID
    Primary 00627825013550
    Package 10627825013557
    Package 20627825013554