Dexcom Replacement Receiver Kit (Medicare)

GUDID 00386270000842

Replacement Receiver Kit (Medicare)

Dexcom, Inc.

Percutaneous glucose monitoring system

• Primary Device ID: 00386270000842
• NIH Device Record Key: d3a1689e-4911-4942-8df9-9bf44c2b5499
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dexcom Replacement Receiver Kit (Medicare)
• Version Model Number: STR-MD-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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386270000842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120005

FDA Product Code

• PQF: Sensor, Glucose, Invasive, Non-Adjunctive

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: 2018-02-05

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)