BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DriDye 492

    DI: 00850229007164 · Model: 492 · AWARENESS TECHNOLOGY, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DriDye 492
    Primary DI
    00850229007164
    Version / Model
    492
    Catalog Number
    E002-492
    Company Name
    AWARENESS TECHNOLOGY, INCORPORATED
    Labeler DUNS
    071065130
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-30
    Public Version
    6
    Public Version Date
    2022-12-20
    Public Version Status
    Update
    Public Device Record Key
    c04e776a-9dde-4ce7-bd7d-a8462d2e7c0f

    Device Description

    Analyzer Quality Control

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    58048 Optical laboratory instrument performance standard calibrator/control IVD, single-use

    Identifiers

    Type ID
    Primary 00850229007164