Eversense® Adhesive Patches, 10-pack Clear

Basic Information

• Brand Name: Eversense® Adhesive Patches, 10-pack Clear
• Primary DI: 00817491021335
• Version / Model: FG-6400-01-300
• Catalog Number: N/A
• Company Name: SENSEONICS, INCORPORATED
• Labeler DUNS: 966865636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-07-16
• Public Version: 2
• Public Version Date: 2019-11-27
• Public Version Status: Update
• Public Device Record Key: 826e5f07-19d8-4e1b-93f9-637f6ace6b3b

Device Description

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.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• 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
QCD	Continuous Glucose Monitor, Implanted, Adjunctive Use	Unknown		3
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	00817491021335	GS1
Unit of Use	00817491021359	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160048	000

Storage Conditions

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