BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OC-Auto

    DI: 00816917021041 · Model: OCPU-GHS2 · POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OC-Auto
    Primary DI
    00816917021041
    Version / Model
    OCPU-GHS2
    Company Name
    POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
    Labeler DUNS
    078413594
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-29
    Public Version
    1
    Public Version Date
    2022-05-09
    Public Version Status
    New
    Public Device Record Key
    5af2ed54-5a2d-4e62-a0cc-3b711e73a10e

    Device Description

    Personal Use Kit OC-Auto, for Gundersen Moundview

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    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
    OOX Automated Occult Blood Analyzer

    GMDN Terms

    Code Name
    54533 Faecal occult blood IVD, reagent

    Identifiers

    Type ID
    Primary 00816917021041

    Premarket Submissions

    Submission Number Supplement Number
    K041408 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius