BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Calibrant Fluid Pack

    DI: 06944413803114 · Model: CP100 · Edan Instruments, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Calibrant Fluid Pack
    Primary DI
    06944413803114
    Version / Model
    CP100
    Company Name
    Edan Instruments, Inc.
    Labeler DUNS
    529173163
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    89ca4627-a974-4150-9d83-8a56ec14917b

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    Yes
    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

    Product Codes

    Code Name
    JIX Calibrator, Multi-Analyte Mixture

    GMDN Terms

    Code Name
    52859 Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

    Identifiers

    Type ID
    Package 06944413803107
    Package 06944413801882
    Primary 06944413803114

    Premarket Submissions

    Submission Number Supplement Number
    K151978 000