Dexcom Studio

GUDID 10386270000146

Dexcom Studio Bundle

Dexcom, Inc.

Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical

• Primary Device ID: 10386270000146
• NIH Device Record Key: 17055367-10e3-4d52-ace5-7a47e2b3e3db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dexcom Studio
• Version Model Number: MT21190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386270000146 [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: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2014-09-12

On-Brand Devices [Dexcom Studio]

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