AccessGUDID - DEVICE: My Dose Coach (04030685900018)

GUDID

Device Identifier (DI) Information

Brand Name: My Dose Coach
Version or Model: 2.x.x
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N/A
Company Name: Sanofi-Aventis Deutschland GmbH

Primary DI Number: 04030685900018
Issuing Agency: GS1
Commercial Distribution End Date: March 22, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 313218430 *Terms of Use
Previous DI: 04030685900001

Device Description: Insulin Titration App

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?
61087	Clinical management support software	An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.	Active	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
Special Storage Condition, Specify: No storage conditions

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: No size - Software as a Medical Device

Device Record Status

Public Device Record Key: 6bfb173e-c31a-4d91-b6f7-acde26be48b6
Public Version Date: October 21, 2024
Public Version Number: 5
DI Record Publish Date: November 23, 2020