BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ACCU-CHEK PERFORMA

    DI: 00365702457102 · Model: 05959551001 · Roche Diagnostics Operations, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ACCU-CHEK PERFORMA
    Primary DI
    00365702457102
    Version / Model
    05959551001
    Catalog Number
    05959551001
    Company Name
    Roche Diagnostics Operations, Inc.
    Labeler DUNS
    141608724
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-26
    Public Version
    4
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    752ebefd-e1a7-478d-8ee5-f91e67320926
    Distribution End Date
    2021-01-14

    Device Description

    ACCU-CHEK PERFORMA PROF METER KIT US F2

    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
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    53301 Glucose IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00365702457102