gammaCore Sapphire SLC Device Kit 12016-04002

GUDID 00815203020546

gammaCore Sapphire SLC 93-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.

ELECTROCORE, LLC

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• Primary Device ID: 00815203020546
• NIH Device Record Key: 1c64d6cc-b99e-4d93-a472-590c3639dd72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore Sapphire SLC Device Kit
• Version Model Number: 12016-04002
• Catalog Number: 12016-04002
• 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
• 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
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not bend or fold the Refill Card
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not bend or fold the Refill Card
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not bend or fold the Refill Card
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not bend or fold the Refill Card
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not bend or fold the Refill Card
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not bend or fold the Refill Card
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not bend or fold the Refill Card
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not bend or fold the Refill Card

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815203020546 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-12
• Device Publish Date: 2021-08-04

On-Brand Devices [gammaCore Sapphire SLC Device Kit]

• 00815203021741: gammaCore Sapphire R 12-Month Device Kit is intended to provide nVNS stimulation on side of neck
• 00815203021734: gammaCore Sapphire R 93-Day Device Kit is intended to provide nVNS stimulation on side of neck
• 00815203020546: gammaCore Sapphire SLC 93-Day Device Kit is intended to provide nVNS stimulation on side of neck
• 00815203020539: gammaCore Sapphire SLC 31-Day Device Kit is intended to provide nVNS stimulation on side of neck