BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eurotrol GlucoTrol-NG

    DI: 08718734960607 · Model: GlucoTrol-NG Level 4 · Eurotrol B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Eurotrol GlucoTrol-NG
    Primary DI
    08718734960607
    Version / Model
    GlucoTrol-NG Level 4
    Catalog Number
    170.004.002
    Company Name
    Eurotrol B.V.
    Labeler DUNS
    412925992
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-08
    Public Version
    1
    Public Version Date
    2020-10-16
    Public Version Status
    New
    Public Device Record Key
    e17a9eac-f172-4cc1-9eab-8fcb5151df80

    Device Description

    Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.

    Device Characteristics

    Single Use
    No
    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
    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
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Package 08718734960591
    Primary 08718734960607

    Premarket Submissions

    Submission Number Supplement Number
    K964053 000