Eversense® Mobile App Android

Basic Information

• Brand Name: Eversense® Mobile App Android
• Primary DI: 00817491023612
• Version / Model: FG-5502-01-300
• Catalog Number: FG-5502-01-300
• Company Name: SENSEONICS, INCORPORATED
• Labeler DUNS: 966865636
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-02
• Public Version: 2
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 7ffdc744-b585-440e-be06-18907102f2b2
• Distribution End Date: 2023-06-20

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QHJ	Sensor, Glucose, Implanted, Non-Adjunctive Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61915	Implantable glucose monitoring system	An assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It typically consists of a sterile, subcutaneously-implanted sensor with dedicated implantation devices (e.g., blunt dissector, introducer needle), and an externally worn transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817491023612	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P160048	006