Dexcom G5 Mobile/G4 Platinum Sensor Kit 1 PK US

GUDID 10386270000214

G5 Mobile/G4 Platinum Sensor Kit 1 PK US

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: 10386270000214
• NIH Device Record Key: 4748ef87-61ce-4a78-90dd-a0d7bbba2fd0
• Commercial Distribution Discontinuation: 2017-02-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Dexcom G5 Mobile/G4 Platinum Sensor Kit 1 PK US
• Version Model Number: STS-GF-011
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386270000214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120005

FDA Product Code

• MDS: Sensor, Glucose, Invasive

Sterilization

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

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

[10386270000214]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2017-02-07

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