Eversense E3 Sensor Kit - Retail FG-7201-00-301

GUDID 00817491022967

Eversense E3 Sensor Kit contains one Eversense E3 Pouch containing a Sensor in Sensor holder.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor Implantable glucose monitoring system sensor

• Primary Device ID: 00817491022967
• NIH Device Record Key: 6214fc3f-527b-49ff-9cca-ec38c4b3e250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense E3 Sensor Kit - Retail
• Version Model Number: FG-7201-00-301
• Catalog Number: FG-7201-00-301
• 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: true
• Serial Number: true
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491022967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160048

FDA Product Code

• QHJ: Sensor, Glucose, Implanted, Non-Adjunctive Use

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: 2022-03-18
• Device Publish Date: 2022-03-10

Devices Manufactured by SENSEONICS, INCORPORATED

• 00817491023841 - Eversense Charging Cable: 2023-12-13 The Micro USB Cable is used to charge Eversense Transmitter
• 00817491023858 - Eversense Power Adapter: 2023-12-13 Power Adapter (i.e., wall plug)
• 00817491023605 - Eversense® Mobile App iOS: 2022-06-10 Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and d
• 00817491023612 - Eversense® Mobile App Android: 2022-06-10 Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet)
• 00817491022882 - Eversense E3 Adhesive Patches Kit, 180-pack: 2022-03-18 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone
• 00817491022905 - Eversense E3 Insertion Tools Kit: 2022-03-18 Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor ins
• 00817491022912 - Eversense E3 Smart Transmitter Kit: 2022-03-18 Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Gui
• 00817491022929 - Eversense E3 Smart Transmitter Kit - Retail: 2022-03-18 Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Gui