MDN GlucoStabilizer® Insulin Dosing Calculator - MDN GlucoStabilizer® Insulin Dosing Calculator is - MEDICAL DECISION NETWORK, LLC

Duns Number:079365279

Device Description: MDN GlucoStabilizer® Insulin Dosing Calculator is designed for use by order of a physician 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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MDN GlucoStabilizer® Insulin Dosing Calculator

Version/Model Number

Insulin Dosing Calculator

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NDC

Product Code Name

Calculator, Drug Dose

Device Record Status

Public Device Record Key

cf0defb5-34cd-4ad0-9875-7e0fc0d86e5e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL DECISION NETWORK, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1