BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Accu-Chek Compact Plus

    DI: 00075537474198 · Model: 05599415160 · Roche Diabetes Care GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    3

    Basic Information

    Brand Name
    Accu-Chek Compact Plus
    Primary DI
    00075537474198
    Version / Model
    05599415160
    Catalog Number
    05599415160
    Company Name
    Roche Diabetes Care GmbH
    Labeler DUNS
    313212471
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2016-08-25
    Public Version
    4
    Public Version Date
    2023-07-25
    Public Version Status
    Update
    Public Device Record Key
    15f41180-f8fb-44f8-86c6-b17b65b3938b
    Distribution End Date
    2020-07-16

    Device Description

    ACCU-CHEK COMPACT PLUS 51 CT RTL STR 48

    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
    No
    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
    LFR Glucose Dehydrogenase, Glucose

    GMDN Terms

    Code Name
    62645 Glucose analyser IVD, home-use

    Identifiers

    Type ID
    Primary 00075537474198
    Unit of Use 50075537474193
    Package 10075537474195

    Premarket Submissions

    Submission Number Supplement Number
    K113614 000