BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rosie

    DI: 00816042013287 · Model: RealTime · FORA CARE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rosie
    Primary DI
    00816042013287
    Version / Model
    RealTime
    Company Name
    FORA CARE INC.
    Labeler DUNS
    004340807
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-05
    Public Version
    1
    Public Version Date
    2018-11-05
    Public Version Status
    New
    Public Device Record Key
    485ed87a-e132-41f4-a0b8-7c713450ad29

    Device Description

    Blood Glucose Monitoring System

    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
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    62646 Glucose analyser IVD, point-of-care

    Identifiers

    Type ID
    Primary 00816042013287