gammaCore-2 10016-40311

GUDID 00815203020119

gammaCore-2 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. It can be programmed to deliver 24 doses per day for 31, 62, or 93 days (up to 99 days max). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

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: 00815203020119
• NIH Device Record Key: 4cce7bf8-f0b0-4b30-8460-09c523cb219f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore-2
• Version Model Number: 10016-40311
• Catalog Number: 10016-40311
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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	00815203020119 [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

On-Brand Devices [gammaCore-2]

• 00815203020126: gammaCore-2 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeabl
• 00815203020119: gammaCore-2 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeabl
• 00815203020102: gammaCore-2 is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeabl