My Dose Coach N/A

GUDID 04030685900001

Insulin Titration App

Sanofi-Aventis Deutschland GmbH

Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software 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
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• 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
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• 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

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