Nerivio

Basic Information

• Brand Name: Nerivio
• Primary DI: 07290017578026
• Version / Model: FGD000075
• Company Name: Theranica Bio-Electronics Ltd.
• Labeler DUNS: 532352807
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-10
• Public Version: 2
• Public Version Date: 2023-03-08
• Public Version Status: Update
• Public Device Record Key: 0fba07f1-db7d-4e1b-aa15-1b5fbeb483e8

Device Description

Refill pack for Nerivio device

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
QGT	Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine	Neurology	882.5899	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60682	Craniofacial analgesia electrical stimulator	A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017578026	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 80.6 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 40 – 50 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal