gammaCore Sapphire 3 11016-40301

GUDID 00815203020423

gammaCore Sapphire 3 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 24 doses per day for 93 days. 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

• Primary Device ID: 00815203020423
• NIH Device Record Key: 3c9ae2a5-eb87-4a19-a9ce-3038c1b46e15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore Sapphire 3
• Version Model Number: 11016-40301
• Catalog Number: 11016-40301
• 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

Operating and Storage Conditions

• 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	00815203020423 [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: 2019-10-23
• Device Publish Date: 2019-10-14

Devices Manufactured by ELECTROCORE, LLC

• 00815203020539 - gammaCore Sapphire SLC Device Kit: 2021-08-12 gammaCore Sapphire SLC 31-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute trea
• 00815203020546 - gammaCore Sapphire SLC Device Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute trea
• 00815203020553 - gammaCore Sapphire SLC DEMO Device Kit: 2021-08-12 gammaCore Sapphire SLC 62-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the applicati
• 00815203020560 - gammaCore Sapphire SLC DEMO Device Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the applicati
• 00815203020614 - gammaCore Sapphire SLC Refill Card Kit: 2021-08-12 gammaCore Sapphire SLC 31-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is inten
• 00815203020621 - gammaCore Sapphire SLC Refill Card Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is inten
• 00815203021260 - gammaCore Sapphire Device Starter Kit: 2021-08-12 gammaCore Sapphire 93-Day Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck
• 00815203021277 - gammaCore Sapphire Device Starter Kit: 2021-08-12 gammaCore Sapphire 6-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of nec