BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Air/Water Valve

    DI: 04953170064180 · Model: MB-196 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Air/Water Valve
    Primary DI
    04953170064180
    Version / Model
    MB-196
    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
    2022-04-08
    Public Version Status
    Update
    Public Device Record Key
    687fc100-74c1-463c-8bd5-5c4dc982c920
    Distribution End Date
    2022-04-01

    Device Description

    "MB-196 AIR/WATER VALVE F/OES FIBERSCOPE"

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "High-level Disinfectant"]

    Product Codes

    Code Name
    FET Endoscopic video imaging system/component, gastroenterology-urology

    GMDN Terms

    Code Name
    61792 Endoscopic procedure air/water valve, reusable

    Identifiers

    Type ID
    Primary 04953170064180

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K853585 000