BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CooperSurgical, Inc.

    DI: 60888937003248 · Model: 47-9005 · Coopersurgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CooperSurgical, Inc.
    Primary DI
    60888937003248
    Version / Model
    47-9005
    Company Name
    Coopersurgical, Inc.
    Labeler DUNS
    801895244
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    5
    Public Version Date
    2024-02-28
    Public Version Status
    Update
    Public Device Record Key
    65075d98-7480-4c50-b467-3a09b152d119

    Device Description

    Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    GBA Catheter, Balloon Type

    GMDN Terms

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

    Identifiers

    Type ID
    Package 30888937003247
    Primary 60888937003248
    Package 20888937003240