Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear FG-6403-01-300

GUDID 00817491021311

Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system

• Primary Device ID: 00817491021311
• NIH Device Record Key: 450b41cd-c3ae-4979-b8f9-dc17626c7236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear
• Version Model Number: FG-6403-01-300
• Catalog Number: FG-6403-01-300
• Company DUNS: 966865636
• Company Name: SENSEONICS, INCORPORATED
• 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: 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: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491021311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160048

FDA Product Code

• QCD: Continuous Glucose Monitor, Implanted, Adjunctive Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-07-16

Devices Manufactured by SENSEONICS, INCORPORATED

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• 00817491024220 - Pouch Containing Grafted Sensor and Holder, Eversense 365: 2024-10-01 Pouch contains one Eversense 365 Sensor in a Sensor holder.
• 00817491024237 - Eversense 365 Smart Transmitter Kit (DME): 2024-10-01 Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a
• 00817491024244 - Eversense 365 Smart Transmitter Kit (Retail): 2024-10-01 Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a
• 00817491024251 - Eversense 365 Smart Transmitter Kit (Provider Purchase): 2024-10-01 Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a
• 00817491024268 - Eversense 365 Mobile Application (iOS): 2024-10-01 Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) an
• 00817491024275 - Eversense 365 Mobile Application (Android): 2024-10-01 Eversense 365 Mobile Application for Android is a software application that runs on a mobile device (e.g., smart phone or tablet
• 00817491024282 - Eversense 365 Sensor Kit (DME): 2024-10-01 Eversense 365 Sensor Kit contains one Eversense 365 Pouch containing a Sensor in Sensor holder.