BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BALLOON CONTROL UNIT

    DI: 04953170239533 · Model: OBCU · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BALLOON CONTROL UNIT
    Primary DI
    04953170239533
    Version / Model
    OBCU
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    7
    Public Version Date
    2023-01-16
    Public Version Status
    Update
    Public Device Record Key
    faf87874-571b-4276-897c-1e81dbe68af1
    Distribution End Date
    2022-08-09

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FDA Enteroscope and accessories
    FED endoscopic access overtube, gastroenterology-urology
    NWB Endoscope, accessories, narrow band spectrum

    GMDN Terms

    Code Name
    46662 Catheter/overtube balloon inflator, reusable

    Identifiers

    Type ID
    Primary 04953170239533

    Customer Contacts

    Phone
    +1(800)401-1086
    Email
    [email protected]