Dexcom G6 Sensor Applicator Assembly

GUDID 00386270000255

G6 Sensor Applicator Assembly

Dexcom, Inc.

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

• Primary Device ID: 00386270000255
• NIH Device Record Key: a89e24e1-d6da-4180-8147-e6d286ac6a72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dexcom G6 Sensor Applicator Assembly
• Version Model Number: 9500-45
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386270000255 [Primary]
GS1	00386270000866 [Package]; Package: BOX [3 Units]; In Commercial Distribution
GS1	00386270001047 [Package]; Package: Box [3 Units]; In Commercial Distribution
GS1	40386270000253 [Package]; Package: BOX [1 Units]; In Commercial Distribution
GS1	50386270000250 [Package]; Package: BOX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170088

FDA Product Code

• QBJ: Integrated Continuous Glucose Monitoring System, Factory Calibrated

Sterilization

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

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

[00386270000255]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-25

Devices Manufactured by Dexcom, Inc.

• 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)
• 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