gammaCore-2

Basic Information

• Brand Name: gammaCore-2
• Primary DI: 00815203020119
• Version / Model: 10016-40311
• Catalog Number: 10016-40311
• Company Name: ELECTROCORE, LLC
• Labeler DUNS: 831341628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-06
• Public Version: 3
• Public Version Date: 2020-05-21
• Public Version Status: Update
• Public Device Record Key: 4cce7bf8-f0b0-4b30-8460-09c523cb219f

Device Description

gammaCore-2 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It can be programmed to deliver 24 doses per day for 31, 62, or 93 days (up to 99 days max). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

Device Characteristics

• Single Use: No
• 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 Unsafe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	882.5892	2
QAK	Non-Invasive Vagus Nerve Stimulator For Migraine Headache	Neurology	882.5892	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58832	Migraine-therapy peripheral nerve electrical stimulator	A portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls, user display, and metal skin contact surfaces that enable application of the electrical signal intended to provide a localized oscillating electric field; it may be used in conjunction with a smartphone. The device is typically used with conductive gel and may be operated by a patient or healthcare provider in the home and healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815203020119	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Replace protective cover after use to protect the treatment surfaces from damage.
• Type: Handling Environment Temperature
• Temperature Range: 0 – 38 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 38 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: – 80 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: – 80 KiloPascal