Eversense 365 Smart Transmitter Kit (Provider Purchase) FG-4002-01-001

GUDID 00817491024817

Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system transmitter

• Primary Device ID: 00817491024817
• NIH Device Record Key: 6b8e3ca1-b875-4133-83df-434004fe8274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense 365 Smart Transmitter Kit (Provider Purchase)
• Version Model Number: FG-4002-01-001
• Catalog Number: FG-4002-01-001
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491024817 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-05
• Device Publish Date: 2026-02-25

On-Brand Devices [Eversense 365 Smart Transmitter Kit (Provider Purchase)]

• 00817491024251: Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessori
• 00817491024817: Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessori