BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ketodoc Blood Glucose Plus B-Ketone Monitoring System

    DI: 00703674534436 · Model: TD-4141 · Rediston Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ketodoc Blood Glucose Plus B-Ketone Monitoring System
    Primary DI
    00703674534436
    Version / Model
    TD-4141
    Company Name
    Rediston Limited
    Labeler DUNS
    663519773
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-17
    Public Version
    3
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    178ea783-053f-40d6-a1ca-d8057bac524a

    Device Description

    Lancing device*1 Lancet*20pcs Blood glucose test strip*10pcs Ketone test strip*10pcs

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    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
    62643 Multiple clinical chemistry analyte monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 00703674534436