BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas IT 1000

    DI: 04015630035342 · Model: 04420306001 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    cobas IT 1000
    Primary DI
    04015630035342
    Version / Model
    04420306001
    Catalog Number
    04420306001
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-21
    Public Version
    1
    Public Version Date
    2020-12-29
    Public Version Status
    New
    Public Device Record Key
    da8bdf83-2b26-428e-af62-334ec24586dc

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JQP Calculator/data processing module, for clinical use

    GMDN Terms

    Code Name
    44082 Clinical laboratory information system application software

    Identifiers

    Type ID
    Primary 04015630035342