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    FDA UDI In Commercial Distribution 🇺🇸 United States

    AmeriWater 00BC55-55 Bicarb Mix and Distribution System

    DI: 00817927020055 · Model: 00BC55-55 · AMERIWATER, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AmeriWater 00BC55-55 Bicarb Mix and Distribution System
    Primary DI
    00817927020055
    Version / Model
    00BC55-55
    Company Name
    AMERIWATER, LLC
    Labeler DUNS
    836758342
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-05
    Public Version
    4
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    38d4d2ca-573b-4b3d-abf9-7fcedadecd2c

    Device Description

    Dual Tank Bicarb Mix and Distribution System, 55 Gallon

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Liquid Chemical", "Ozone", "High-level Disinfectant"]

    Product Codes

    Code Name
    FIN Tank, Holding, Dialysis

    GMDN Terms

    Code Name
    36345 Haemodialysis bicarbonate solution preparation mixer

    Identifiers

    Type ID
    Primary 00817927020055

    Premarket Submissions

    Submission Number Supplement Number
    K051031 000