Eversense® Mobile App iOS FG-5501-01-300

GUDID 00817491022370

Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system

• Primary Device ID: 00817491022370
• NIH Device Record Key: c3be7e2e-ac28-4914-a15f-d92b58b64e47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense® Mobile App iOS
• Version Model Number: FG-5501-01-300
• Catalog Number: FG-5501-01-300
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491022370 [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: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [Eversense® Mobile App iOS]

• 00817491020819: Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e
• 00817491022370: Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e
• 00817491023605: Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e