Home GUDID 00815203020102
gammaCore-2
Primary DI 00815203020102
Brand gammaCore-2
Company electroCore, Inc.
Model 10016-40310
Catalog number 10016-40310
Device description 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.
Published 2018-04-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Product Codes# Code, Name table Code Name PKR Non-Invasive Vagus Nerve Stimulator - Headache QAK Non-Invasive Vagus Nerve Stimulator For Migraine Headache
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PKR Non-Invasive Vagus Nerve Stimulator - Headache Neurology 2 QAK Non-Invasive Vagus Nerve Stimulator For Migraine Headache Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815203020102 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815203020102 00815203020102 815203020102 0815203020102
GMDN Terms# Term, Definition table Term Definition Migraine-therapy peripheral nerve electrical stimulator A portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls, user display, and metal skin contact surfaces that enable application of the electrical signal intended to provide a localized oscillating electric field; it may be used in conjunction with a smartphone. The device is typically used with conductive gel and may be operated by a patient or healthcare provider in the home and healthcare facility. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 KiloPascal 80 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 0 Degrees Celsius 38 Degrees Celsius Special Storage Condition, Specify 0 0 Replace protective cover after use to protect the treatment surfaces from damage. Storage Environment Atmospheric Pressure 0 KiloPascal 80 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 38 Degrees Celsius
Regulatory Flags# DUNS number 831341628 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00815203020089 gammaCore Sapphire 20016-00301-RPL 20016-00301-RPL 2026-02-16 00815203021864 gammaCore Sapphire 20016-00501-RPL 20016-00501-RPL 2026-02-16 00815203022045 gammaCore Sapphire 13016-04501-C 13016-04501-C 2026-02-16 00815203022052 gammaCore Sapphire 13016-04502-C 13016-04502-C 2026-02-16 00815203022076 gammaCore Sapphire 13016-04504-C 13016-04504-C 2026-02-16 00815203022236 gammaCore Sapphire 12016-04999 12016-04999 2026-02-16 00815203022441 gammaCore 20016-00003-RPL 20016-00003-RPL 2026-02-16 00815203022458 gammaCore 20016-00006-RPL 20016-00006-RPL 2026-02-16 00815203022687 gammaCore Sapphire 20016-00502-RPL 20016-00502-RPL 2026-02-16 00815203022694 gammaCore Emerald 20116-00001-RPL 20116-00001-RPL 2026-02-16 00815203022700 gammaCore Emerald 20116-10301-RPL 20116-10301-RPL 2026-02-16 00815203022717 gammaCore Emerald 50022-00004-RPL 50022-00004-RPL 2026-02-16 00815203022724 gammaCore Emerald 50022-00078-RPL 50022-00078-RPL 2026-02-16 00815203022427 gammaCore Sapphire AC Power Adapter 20016-00001-RPL 20016-00001-RPL 2026-01-28 00815203022472 gammaCore Emerald 3-Month Device Kit 12116-04003 12116-04003 2026-01-14 00815203022489 gammaCore Emerald 12-Month Device Kit 12116-04012 12116-04012 2026-01-14 00815203022496 gammaCore Emerald-D Device Kit 12116-04036 12116-04036 2026-01-14 00815203022502 gammaCore Emerald 6-Month Evaluation Device Kit 11116-04006 11116-04006 2026-01-14 00815203022519 gammaCore 1-Month Refill Kit 12116-04501 12116-04501 2026-01-14 00815203022526 gammaCore 3-Month Refill Kit 12116-04503 12116-04503 2026-01-14
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00815203020089 gammaCore Sapphire electroCore, Inc. PKR 2026-02-16 00815203020089 gammaCore Sapphire electroCore, Inc. QAK 2026-02-16 00815203021864 gammaCore Sapphire electroCore, Inc. PKR 2026-02-16 00815203021864 gammaCore Sapphire electroCore, Inc. QAK 2026-02-16 00815203022045 gammaCore Sapphire electroCore, Inc. QAK 2026-02-16 00815203022045 gammaCore Sapphire electroCore, Inc. PKR 2026-02-16 00815203022052 gammaCore Sapphire electroCore, Inc. QAK 2026-02-16 00815203022052 gammaCore Sapphire electroCore, Inc. PKR 2026-02-16 00815203022076 gammaCore Sapphire electroCore, Inc. QAK 2026-02-16 00815203022076 gammaCore Sapphire electroCore, Inc. PKR 2026-02-16 00815203022236 gammaCore Sapphire electroCore, Inc. QAK 2026-02-16 00815203022236 gammaCore Sapphire electroCore, Inc. PKR 2026-02-16 00815203022441 gammaCore electroCore, Inc. QAK 2026-02-16 00815203022441 gammaCore electroCore, Inc. PKR 2026-02-16 00815203022458 gammaCore electroCore, Inc. PKR 2026-02-16 00815203022458 gammaCore electroCore, Inc. QAK 2026-02-16 00815203022687 gammaCore Sapphire electroCore, Inc. QAK 2026-02-16 00815203022687 gammaCore Sapphire electroCore, Inc. PKR 2026-02-16 00815203022694 gammaCore Emerald electroCore, Inc. PKR 2026-02-16 00815203022694 gammaCore Emerald electroCore, Inc. QAK 2026-02-16 00815203022700 gammaCore Emerald electroCore, Inc. QAK 2026-02-16 00815203022700 gammaCore Emerald electroCore, Inc. PKR 2026-02-16 00815203022717 gammaCore Emerald electroCore, Inc. PKR 2026-02-16 00815203022717 gammaCore Emerald electroCore, Inc. QAK 2026-02-16 00815203022724 gammaCore Emerald electroCore, Inc. QAK 2026-02-16 00815203022724 gammaCore Emerald electroCore, Inc. PKR 2026-02-16 00815203022427 gammaCore Sapphire AC Power Adapter electroCore, Inc. QAK 2026-01-28 00815203022427 gammaCore Sapphire AC Power Adapter electroCore, Inc. PKR 2026-01-28 00815203022472 gammaCore Emerald 3-Month Device Kit electroCore, Inc. QAK 2026-01-14 00815203022472 gammaCore Emerald 3-Month Device Kit electroCore, Inc. PKR 2026-01-14