Eversense® Smart Transmitter Kit – Provider Purchase FG-3302-01-001

GUDID 00817491022516

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

SENSEONICS, INCORPORATED

Implantable glucose monitoring system transmitter

• Primary Device ID: 00817491022516
• NIH Device Record Key: 39bc145f-bb8b-4832-a8aa-576ecc32ca8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense® Smart Transmitter Kit – Provider Purchase
• Version Model Number: FG-3302-01-001
• Catalog Number: FG-3302-01-001
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-736-7348
• Email: [email protected]

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491022516 [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: 2019-11-27
• Device Publish Date: 2019-11-19

Devices Manufactured by SENSEONICS, INCORPORATED

• 00817491021908 - Eversense® Charging Accessories Pack: 2019-11-27 Eversense® Charging Accessories Pack contains the Charging Cradle, US Configuration Power Supply and a USB Cable.
• 00817491021458 - Eversense® Smart Transmsitter Kit - Retail: 2019-11-27 Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card.
• 00817491021403 - Eversense® Insertion Tools Tray: 2019-11-27 Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
• 00817491021397 - Eversense® Insertion Tools Kit: 2019-11-27 Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
• 00817491021335 - Eversense® Adhesive Patches, 10-pack Clear: 2019-11-27 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
• 00817491021311 - Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear: 2019-11-27 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
• 00817491021304 - Eversense® Adhesive Patches, 30-Pack White: 2019-11-27 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
• 00817491021328 - Eversense® Adhesive Patches, 30-Pack Clear: 2019-11-27 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.