gammaCore Sapphire 10016-40301

GUDID 00815203020027

gammaCore Sapphire, part number 10016-40301, 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 is programmed to deliver up to 30 doses per day for 10 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via a "Refill Card" encoded and provided by electroCore or its authorized agent. (Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.) The Refill Card will be provided to the user / patient requesting a refill of their device, 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. 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

• Primary Device ID: 00815203020027
• NIH Device Record Key: 3d80ff2a-37c6-449d-8070-0cce47201b10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore Sapphire
• Version Model Number: 10016-40301
• Catalog Number: 10016-40301
• 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	00815203020027 [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 Sapphire]

• 00815203020133: gammaCore Sapphire, part number 10016-40303, is a multi-use, hand-held, rechargeable, portable d
• 00815203020034: gammaCore Sapphire, part number 10016-40302, is a multi-use, hand-held, rechargeable, portable d
• 00815203020027: gammaCore Sapphire, part number 10016-40301, is a multi-use, hand-held, rechargeable, portable d