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    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas b 123 <1> POC system

    DI: 04015630036929 · Model: 5122244001 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    cobas b 123 <1> POC system
    Primary DI
    04015630036929
    Version / Model
    5122244001
    Catalog Number
    5122244001
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    1098e5a0-a88c-4414-80e7-7de6846480ac

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

    GMDN Terms

    Code Name
    56669 Metabolic profile clinical chemistry analyser IVD, stationary, automated

    Identifiers

    Type ID
    Primary 04015630036929

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 50 Degrees Celsius