BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AQUARI IMMERSION CONTROLLER

    DI: 00842430115936 · Model: 246AQI · MIZUHO ORTHOPEDIC SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AQUARI IMMERSION CONTROLLER
    Primary DI
    00842430115936
    Version / Model
    246AQI
    Catalog Number
    246AQI
    Company Name
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Labeler DUNS
    084527241
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-11-26
    Public Version
    1
    Public Version Date
    2021-12-06
    Public Version Status
    New
    Public Device Record Key
    4762eced-5e37-4c65-843d-e42878e80477

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FNM Mattress, Air Flotation, Alternating Pressure

    GMDN Terms

    Code Name
    65167 Operating table patient pressure distribution monitoring/regulation system

    Identifiers

    Type ID
    Primary 00842430115936

    Customer Contacts

    Phone
    1-800-777-4674
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    14 – 131 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    95 – 105 Percent (%) Relative Humidity