BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Accu-Chek Combo

    DI: 04015630883806 · Model: 05458544001 · Roche Diabetes Care GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Accu-Chek Combo
    Primary DI
    04015630883806
    Version / Model
    05458544001
    Catalog Number
    05458544001
    Company Name
    Roche Diabetes Care GmbH
    Labeler DUNS
    313212471
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-25
    Public Version
    3
    Public Version Date
    2023-07-25
    Public Version Status
    Update
    Public Device Record Key
    8f14dc4b-b546-4831-86cd-f28c37fd66be
    Distribution End Date
    2016-09-13

    Device Description

    Accu-Chek Combo Kit mg US/en

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZG Pump, Infusion, Insulin

    GMDN Terms

    Code Name
    51083 Ambulatory insulin infusion pump/blood glucose analyser system

    Identifiers

    Type ID
    Primary 04015630883806