BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accu-Chek Guide Link

    DI: 00365702702295 · Model: 08116083022 · Roche Diagnostics Operations, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Accu-Chek Guide Link
    Primary DI
    00365702702295
    Version / Model
    08116083022
    Company Name
    Roche Diagnostics Operations, Inc.
    Labeler DUNS
    141608724
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-30
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    390c82d5-a922-4b4f-97a7-f009869ee714

    Device Description

    ACCU-CHEK GUIDE LINK FC US MG/DL

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    OZP Automated Insulin Dosing Device System, Single Hormonal Control

    GMDN Terms

    Code Name
    53301 Glucose IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Package 10365702702292
    Primary 00365702702295

    Premarket Submissions

    Submission Number Supplement Number
    P160017 000