gammaCore Emerald 3-Month Licensed Device Kit 13116-04003

GUDID 00815203022564

gammaCore Emerald 3-Month Licensed Device Kit

electroCore, Inc.

Migraine-therapy peripheral nerve electrical stimulator

• Primary Device ID: 00815203022564
• NIH Device Record Key: 70185d75-e9bd-4222-b47b-d76961b67801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore Emerald 3-Month Licensed Device Kit
• Version Model Number: 13116-04003
• Catalog Number: 13116-04003
• Company DUNS: 831341628
• Company Name: electroCore, Inc.
• 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
• 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

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815203022564 [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: 2026-01-22
• Device Publish Date: 2026-01-14

Devices Manufactured by electroCore, Inc.

• 00815203022427 - gammaCore Sapphire AC Power Adapter: 2026-02-05 AC Power Adapter
• 00815203022472 - gammaCore Emerald 3-Month Device Kit: 2026-01-22 A 3-Month Device Kit
• 00815203022489 - gammaCore Emerald 12-Month Device Kit: 2026-01-22 gammaCore Emerald 12-Month Device Kit
• 00815203022496 - gammaCore Emerald-D Device Kit: 2026-01-22 36-Month Device Kit
• 00815203022502 - gammaCore Emerald 6-Month Evaluation Device Kit: 2026-01-22 gammaCore Emerald 6-Month Evaluation Device Kit
• 00815203022519 - gammaCore 1-Month Refill Kit: 2026-01-22 gammaCore Emerald 1 Month Refill Kit
• 00815203022526 - gammaCore 3-Month Refill Kit: 2026-01-22 gammaCore Emerald 3-Month Refill Kit
• 00815203022533 - gammaCore 12-Month Refill Kit: 2026-01-22 gammaCore Emerald 12-Month Refill Kit