Eversense® Insertion Tools Kit FG-8211-01-201

GUDID 00817491021397

Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.

SENSEONICS, INCORPORATED

Subcutaneous implantation kit, non-medicated

• Primary Device ID: 00817491021397
• NIH Device Record Key: f6a52b70-e1cf-4b6f-9cfd-18c5153c4f40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense® Insertion Tools Kit
• Version Model Number: FG-8211-01-201
• Catalog Number: FG-8211-01-201
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491021397 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-07-16

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: 2024-10-01 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.