My Dose Coach N/A

GUDID 04030685900001

Insulin Titration App

Sanofi-Aventis Deutschland GmbH

Clinical management support software

• Primary Device ID: 04030685900001
• NIH Device Record Key: 6bfb173e-c31a-4d91-b6f7-acde26be48b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Dose Coach
• Version Model Number: 2.x.x
• Catalog Number: N/A
• Company DUNS: 313218430
• Company Name: Sanofi-Aventis Deutschland GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com
• Phone: +496930523019
• Email: alexander.valenca@sanofi.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions
• Special Storage Condition, Specify: Between 0 and 0 *No storage conditions

Device Identifiers

Device Issuing Agency	Device ID
GS1	04030685900001 [Previous]
GS1	04030685900018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163099

FDA Product Code

• NDC: Calculator, drug dose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-01
• Device Publish Date: 2020-11-23