BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CK-MB CAL

    DI: 05055273201451 · Model: CK2393 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CK-MB CAL
    Primary DI
    05055273201451
    Version / Model
    CK2393
    Catalog Number
    CK2393
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    76b4cd3a-c7bc-43c2-a624-f8638bf22a8f

    Device Description

    The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems.

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JIT Calibrator, Secondary

    GMDN Terms

    Code Name
    44694 Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

    Identifiers

    Type ID
    Primary 05055273201451

    Customer Contacts

    Phone
    +442894451070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K123977 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Once reconstituted CK-MB is stable in the serum for 5 days at +4°C, 8 hours at +25°C and 4 weeks at –20°C when frozen once.
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius