Pouch Containing Grafted Sensor and Holder, Eversense 365

GUDID 00817491024220

Pouch contains one Eversense 365 Sensor in a Sensor holder.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system sensor

• Primary Device ID: 00817491024220
• NIH Device Record Key: 3ed9a38e-e30a-44ab-8294-6b9382ce57f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pouch Containing Grafted Sensor and Holder, Eversense 365
• Version Model Number: 102606-023
• Company DUNS: 966865636
• Company Name: SENSEONICS, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491024220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241335

FDA Product Code

• SBA: Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-01
• Device Publish Date: 2024-09-23

Devices Manufactured by SENSEONICS, INCORPORATED

• 00817491024046 - Eversense 365 Adhesive Patches Kit: 2024-10-01 Eversense adhesive patches have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side
• 00817491024220 - Pouch Containing Grafted Sensor and Holder, Eversense 365: 2024-10-01Pouch contains one Eversense 365 Sensor in a Sensor holder.
• 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.