BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MISSION U500 URINE ANALYZER

    DI: 20682607200515 · Model: U211-111 · Acon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MISSION U500 URINE ANALYZER
    Primary DI
    20682607200515
    Version / Model
    U211-111
    Catalog Number
    U211-111
    Company Name
    Acon Laboratories, Inc.
    Labeler DUNS
    781100966
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-08
    Public Version
    3
    Public Version Date
    2025-06-20
    Public Version Status
    Update
    Public Device Record Key
    df388dd4-ec5c-4013-ba2e-4b3a00d5b03b

    Device Description

    URINE ANALYZER with Barcode Reader

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    Yes
    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
    No

    Product Codes

    Code Name
    KQO AUTOMATED URINALYSIS SYSTEM

    GMDN Terms

    Code Name
    57861 Urine analyser IVD, point-of-care

    Identifiers

    Type ID
    Primary 20682607200515

    Customer Contacts

    Phone
    +1(800)838-9502 ext. 1
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    32 – 104 Degrees Fahrenheit