BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RX daytona

    DI: 05055273205893 · Model: RX3900 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RX daytona
    Primary DI
    05055273205893
    Version / Model
    RX3900
    Catalog Number
    RX3900
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-07
    Public Version
    4
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    16c1a312-a73f-42f8-a91e-87bc74cf5190

    Device Description

    RX Daytona is an automated clinical chemistry analyser complete with dedicated analyser software.

    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
    No

    Product Codes

    Code Name
    JJF Analyzer, Chemistry, Micro, For Clinical Use

    GMDN Terms

    Code Name
    56676 Multiple clinical chemistry analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 05055273205893

    Customer Contacts

    Phone
    +442894451070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K024014 000