Dexcom Studio

GUDID 00386270000149

Dexcom Studio CD

Dexcom, Inc.

Percutaneous glucose monitoring system

• Primary Device ID: 00386270000149
• NIH Device Record Key: 36d9b318-15af-4628-b500-435c830960a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dexcom Studio
• Version Model Number: MT21360
• Company DUNS: 123160736
• Company Name: Dexcom, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com
• Phone: 1-888-738-3646
• Email: TechSupport@dexcom.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386270000149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120005

FDA Product Code

• MDS: Sensor, Glucose, Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-12

On-Brand Devices [Dexcom Studio]

• 00386270000149: Dexcom Studio CD
• 10386270000146: Dexcom Studio Bundle