gammaCore Sapphire D 11016-40302

GUDID 00815203020430

gammaCore Sapphire D 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. Catalog Number 11016-40302 is programmed to deliver 24 doses per day for 6 months. 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, Inc.

Migraine-therapy peripheral nerve electrical stimulator

• Primary Device ID: 00815203020430
• NIH Device Record Key: ab2135bb-f5c6-4065-baa5-76e84b09a2e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore Sapphire D
• Version Model Number: 11016-40302
• Catalog Number: 11016-40302
• 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

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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.
• 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 *Replace protective cover after use to protect the treatment surfaces from damage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815203020430 [Primary]

FDA Product Code

• QAK: Non-Invasive Vagus Nerve Stimulator For Migraine 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: 2025-12-18
• Device Publish Date: 2020-05-22

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