BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PREVI® COLOR GRAM V2

    DI: 03573026415310 · Model: 414292 · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PREVI® COLOR GRAM V2
    Primary DI
    03573026415310
    Version / Model
    414292
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-14
    Public Version
    2
    Public Version Date
    2022-09-26
    Public Version Status
    Update
    Public Device Record Key
    93722cf5-39ed-4c7a-a05f-5c0e6d488525

    Device Description

    The PREVI Color Gram is an in vitro diagnostic medical device for professional use. It has been designed to gram stain specimen smears on microscope slides.

    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
    Yes
    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
    KPA Slide stainer, automated

    GMDN Terms

    Code Name
    15599 Microscope slide stainer IVD

    Identifiers

    Type ID
    Primary 03573026415310

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 40 Degrees Celsius