Dexcom G6 Receiver Kit

GUDID 00386270000590

G6 Receiver Kit

Dexcom, Inc.

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

• Primary Device ID: 00386270000590
• NIH Device Record Key: dca9b1db-9ec8-4451-8c6e-47ff2a3f56c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dexcom G6 Receiver Kit
• Version Model Number: STK-OR-001
• 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: true
• Serial Number: true
• 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: 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	00386270000590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170088

FDA Product Code

• QBJ: Integrated Continuous Glucose Monitoring System, Factory Calibrated

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: 2023-05-12
• Device Publish Date: 2023-05-04

Devices Manufactured by Dexcom, Inc.

• 00386270004635 - Dexcom Stelo iOS Mobile App: 2024-08-23
• 00386270004642 - Dexcom Stelo Android Mobile App: 2024-08-23
• 00386270004659 - Dexcom Stelo iOS Watch App: 2024-08-23
• 00386270004550 - Dexcom G7 GSS (1): 2024-06-26 G7 GSS US (1pk) -161 (Government Payor)
• 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)