gammaCore Sapphire SLC Device Kit

Basic Information

• Brand Name: gammaCore Sapphire SLC Device Kit
• Primary DI: 00815203020539
• Version / Model: 12016-04001
• Catalog Number: 12016-04001
• Company Name: ELECTROCORE, LLC
• Labeler DUNS: 831341628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-04
• Public Version: 1
• Public Version Date: 2021-08-12
• Public Version Status: New
• Public Device Record Key: c75e65f8-eb7e-4f43-8565-09f14429fd90

Device Description

gammaCore Sapphire SLC 31-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

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	00815203020539	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: – 80 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: – 80 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 38 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 38 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not bend or fold the Refill Card