Dexcom G6 Professional System

GUDID 00386270001092

Dexcom G6 Professional System

Dexcom, Inc.

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 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 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 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 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 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: 00386270001092
• NIH Device Record Key: 11be4fc9-052c-423f-a7dd-c0d620c2e3e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dexcom G6 Professional System
• Version Model Number: STP-PR-001
• Company DUNS: 123160736
• Company Name: Dexcom, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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
• 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	00386270001092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170088

FDA Product Code

• QBJ: Integrated Continuous Glucose Monitoring System, Factory Calibrated
• QII: Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-13
• Device Publish Date: 2023-04-05

Devices Manufactured by Dexcom, Inc.

• 00386270004338 - Stelo Biosensor: 2024-04-03 Stelo Biosensor
• 00386270004345 - Stelo Glucose Biosensor (1pk): 2024-04-03 Stelo Glucose Biosensor US (1pk)
• 00386270004383 - Stelo Glucose Biosensor (2pk): 2024-04-03 Stelo Glucose Biosensor US (2pk)
• 00386270004390 - Stelo Glucose Biosensor (1pk) UPC: 2024-04-03 Stelo Glucose Biosensor US (1pk)
• 00386270004406 - Stelo Glucose Biosensor (2pk) UPC: 2024-04-03 Stelo Glucose Biosensor US (2pk)
• 00386270000378 - Dexcom G7 AR Overlay 10-Pack: 2024-02-26 G7 AR Overlay 10-Pack
• 00386270004017 - Dexcom G7 Overpatch 10 Pack: 2024-02-26 Dexcom G7 Overpatch 10 Pack
• 00386270003478 - Dexcom G7 Sample Pack (155): 2023-09-07 G7 Sample Pack US (1pk) - 155