gammaCore Sapphire SLC DEMO Device Kit 12016-04003

GUDID 00815203020553

gammaCore Sapphire SLC 62-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as 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

Migraine-therapy peripheral nerve electrical stimulator

• Primary Device ID: 00815203020553
• NIH Device Record Key: 62a565fb-fb49-4333-85d6-691557e9aada
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore Sapphire SLC DEMO Device Kit
• Version Model Number: 12016-04003
• Catalog Number: 12016-04003
• 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	00815203020553 [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

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• 00815203021314: gammaCore Sapphire 62-Day DEMO Device Kit (preprogrammed, refillable) is intended to be used to
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