DEVICE: MDN GlucoStabilizer® Insulin Dosing Calculator (00861133000301)

Device Identifier (DI) Information

MDN GlucoStabilizer® Insulin Dosing Calculator
Insulin Dosing Calculator
In Commercial Distribution

MEDICAL DECISION NETWORK, LLC
00861133000301
GS1

1
079365279 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Calculator, programmable A small electronic calculator that can be programmed to carry out calculations related to a specific medical treatment, e.g., measuring infusion dosages, or the degree of stenosis in a coronary vessel where measurements are taken from x-ray films using an electronic calliper coupled to a programmed calculator. Dedicated software may be necessary to effect the device's intended purpose.
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FDA Product Code

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Product Code Product Code Name
NDC Calculator, Drug Dose
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FDA Premarket Submission

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Sterilization

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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Device Record Status

cf0defb5-34cd-4ad0-9875-7e0fc0d86e5e
March 29, 2018
2
September 12, 2016
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Alternative and Additional Identifiers Additional Identifiers

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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