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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORTHO

    DI: 10758750005451 · Model: 936396 · ORTHO-CLINICAL DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ORTHO
    Primary DI
    10758750005451
    Version / Model
    936396
    Catalog Number
    936396
    Company Name
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Labeler DUNS
    068715424
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-24
    Public Version
    5
    Public Version Date
    2023-06-21
    Public Version Status
    Update
    Public Device Record Key
    78004a9b-3cdf-4d2b-96c6-831ed7ca3c49

    Device Description

    OSP Workstation, 166 MHz (computer)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    MZA TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN

    GMDN Terms

    Code Name
    56718 Enzyme immunoassay (EIA) analyser IVD

    Identifiers

    Type ID
    Primary 10758750005451

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -15 – 45 Degrees Celsius