BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    cobas 8000 c 701 Module

    DI: 04015630928255 · Model: 5641489001 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    cobas 8000 c 701 Module
    Primary DI
    04015630928255
    Version / Model
    5641489001
    Catalog Number
    5641489001
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    4
    Public Version Date
    2020-11-11
    Public Version Status
    Update
    Public Device Record Key
    f42afeb7-8b59-4c8a-a139-2efc8c1508be
    Distribution End Date
    2018-07-02

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

    GMDN Terms

    Code Name
    61927 Multi-modality clinical specimen analysis system IVD

    Identifiers

    Type ID
    Primary 04015630928255

    Premarket Submissions

    Submission Number Supplement Number
    K100853 000