BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GLUCOCARD® Expression™ Level 2 Control Solution

    DI: 00015482570071 · Model: 570007 · ARKRAY USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GLUCOCARD® Expression™ Level 2 Control Solution
    Primary DI
    00015482570071
    Version / Model
    570007
    Company Name
    ARKRAY USA, INC.
    Labeler DUNS
    008171162
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-25
    Public Version
    1
    Public Version Date
    2018-10-26
    Public Version Status
    New
    Public Device Record Key
    12975523-4c34-4651-9dd6-6daf4daaa1c1

    Device Description

    GLUCOCARD Expression Level 2 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570071 is used as the assigned UDI for the Class I device.)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 00015482570071

    Customer Contacts

    Phone
    1-800-566-8558
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K102037 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    59 – 86 Degrees Fahrenheit