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    FDA UDI In Commercial Distribution 🇺🇸 United States

    MDN GlucoStabilizer® Insulin Dosing Calculator

    DI: 00861133000301 · Model: Insulin Dosing Calculator · MEDICAL DECISION NETWORK, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MDN GlucoStabilizer® Insulin Dosing Calculator
    Primary DI
    00861133000301
    Version / Model
    Insulin Dosing Calculator
    Company Name
    MEDICAL DECISION NETWORK, LLC
    Labeler DUNS
    079365279
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    cf0defb5-34cd-4ad0-9875-7e0fc0d86e5e

    Device Description

    MDN GlucoStabilizer® Insulin Dosing Calculator is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the blood glucose level either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system’s function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient’s blood glucose level in that target range. The system is programmed to provide dosing calculations of insulin and dextrose for both adult and pediatric (ages 2-18) patients.

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NDC Calculator, Drug Dose

    GMDN Terms

    Code Name
    36727 Calculator, programmable

    Identifiers

    Type ID
    Primary 00861133000301