BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Procleix System Fluid Preservative

    DI: 00859882007412 · Model: Procleix System Fluid Preservative Kit · GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Procleix System Fluid Preservative
    Primary DI
    00859882007412
    Version / Model
    Procleix System Fluid Preservative Kit
    Company Name
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    Labeler DUNS
    056570085
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-03
    Public Version
    2
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    f679a8ed-3251-4234-b28d-ca098b7296ae

    Device Description

    A buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    58237 Buffered sample diluent IVD

    Identifiers

    Type ID
    Primary 00859882007412