Eversense® Smart Transmitter Kit – Provider Purchase

Basic Information

• Brand Name: Eversense® Smart Transmitter Kit – Provider Purchase
• Primary DI: 00817491022516
• Version / Model: FG-3302-01-001
• Catalog Number: FG-3302-01-001
• Company Name: SENSEONICS, INCORPORATED
• Labeler DUNS: 966865636
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-19
• Public Version: 2
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 39bc145f-bb8b-4832-a8aa-576ecc32ca8e
• Distribution End Date: 2023-06-20

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
61912	Implantable glucose monitoring system transmitter	A body-worn, battery-powered component of an implantable glucose monitoring system designed to wirelessly transmit glucose measurements continuously from the implanted sensor to a receiver (e.g., a mobile device). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817491022516	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160048	006

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 95 Degrees Fahrenheit