gammaCore Refill Card 93-Day 10016-43193

GUDID 00815203020065

Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a "gammaCore Refill Card" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away.

ELECTROCORE, LLC

Migraine-therapy peripheral nerve electrical stimulator Migraine-therapy peripheral nerve electrical stimulator Migraine-therapy peripheral nerve electrical stimulator Migraine-therapy peripheral nerve electrical stimulator Migraine-therapy peripheral nerve electrical stimulator Migraine-therapy peripheral nerve electrical stimulator

• Primary Device ID: 00815203020065
• NIH Device Record Key: b2442b2f-bdcc-44aa-9562-84545329ecc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore Refill Card 93-Day
• Version Model Number: 10016-43193
• Catalog Number: 10016-43193
• Company DUNS: 831341628
• Company Name: ELECTROCORE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815203020065 [Primary]

FDA Product Code

• PKR: Non-Invasive Vagus Nerve Stimulator - Headache

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-04-06

Devices Manufactured by ELECTROCORE, LLC

• 00815203020539 - gammaCore Sapphire SLC Device Kit: 2021-08-12 gammaCore Sapphire SLC 31-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute trea
• 00815203020546 - gammaCore Sapphire SLC Device Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute trea
• 00815203020553 - gammaCore Sapphire SLC DEMO Device Kit: 2021-08-12 gammaCore Sapphire SLC 62-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the applicati
• 00815203020560 - gammaCore Sapphire SLC DEMO Device Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the applicati
• 00815203020614 - gammaCore Sapphire SLC Refill Card Kit: 2021-08-12 gammaCore Sapphire SLC 31-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is inten
• 00815203020621 - gammaCore Sapphire SLC Refill Card Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is inten
• 00815203021260 - gammaCore Sapphire Device Starter Kit: 2021-08-12 gammaCore Sapphire 93-Day Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck
• 00815203021277 - gammaCore Sapphire Device Starter Kit: 2021-08-12 gammaCore Sapphire 6-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of nec