Eversense 365 Sensor Kit (Provider Purchase)

Basic Information

• Brand Name: Eversense 365 Sensor Kit (Provider Purchase)
• Primary DI: 00817491024305
• Version / Model: FG-7502-00-301
• Catalog Number: FG-7502-00-301
• Company Name: SENSEONICS, INCORPORATED
• Labeler DUNS: 966865636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-23
• Public Version: 1
• Public Version Date: 2024-10-01
• Public Version Status: New
• Public Device Record Key: d2687173-5785-4f3a-8755-e27d34641ad0

Device Description

Eversense 365 Sensor Kit contains one Eversense 365 Pouch containing a Sensor in Sensor holder.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SBA	Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate	Clinical Chemistry	862.1357	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61930	Implantable glucose monitoring system sensor	A sterile device intended to be implanted subcutaneously for continuous monitoring of glucose levels in interstitial fluid, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is a small, rod-shaped sensor consisting of an electrochemical or optical glucose detector that emits signals which are sent to an externally-worn transmitter (not included) via a wireless connection. It is passively-powered by the transmitter. Dedicated implantation devices (e.g., blunt dissector, cannula) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817491024305	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K241335	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 46 Degrees Fahrenheit