BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cal Dye Reference Standard

    DI: 08426950008040 · Model: 00003315050 · INSTRUMENTATION LABORATORY COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Cal Dye Reference Standard
    Primary DI
    08426950008040
    Version / Model
    00003315050
    Catalog Number
    00003315050
    Company Name
    INSTRUMENTATION LABORATORY COMPANY
    Labeler DUNS
    557223252
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2021-07-08
    Public Version Status
    Update
    Public Device Record Key
    5300f445-d69f-4ae0-873b-9299a2dae318
    Distribution End Date
    2018-03-09

    Device Description

    Cal Dye Reference Standard

    Device Characteristics

    Single Use
    No
    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
    GKR SYSTEM, HEMOGLOBIN, AUTOMATED

    GMDN Terms

    Code Name
    35933 Multiple blood gas analyte IVD, calibrator

    Identifiers

    Type ID
    Primary 08426950008040
    Unit of Use 18426950008047

    Customer Contacts

    Phone
    18006780710
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    CalDye Reference Standard is stable until the expiration date shown on the product labeling if stored at room temperature (15-25°C).