Eversense E3 Smart Transmitter Kit - Provider Purchase FG-5902-01-001

GUDID 00817491022936

Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.

SENSEONICS, INCORPORATED

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• Primary Device ID: 00817491022936
• NIH Device Record Key: a5a1cd74-44e5-444a-97ce-634fd3dcfe4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense E3 Smart Transmitter Kit - Provider Purchase
• Version Model Number: FG-5902-01-001
• Catalog Number: FG-5902-01-001
• Company DUNS: 966865636
• Company Name: SENSEONICS, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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 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	00817491022936 [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: false

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