AccessGUDID - DEVICE: MDN GlucoStabilizer® Insulin Dosing Calculator (00861133000301)

GUDID

Device Identifier (DI) Information

Brand Name: MDN GlucoStabilizer® Insulin Dosing Calculator
Version or Model: Insulin Dosing Calculator
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDICAL DECISION NETWORK, LLC

Primary DI Number: 00861133000301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079365279 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36727	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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NDC	Calculator, Drug Dose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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