FDA.reportPublic FDA data

gammaCore Refill Card

Primary DI
00815203022786
Brand
gammaCore Refill Card
Company
electroCore, Inc.
Model
12116-00512-C
Device description
12-Month gammaCore Refill Card
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKRNon-Invasive Vagus Nerve Stimulator - Headache
QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKRNon-Invasive Vagus Nerve Stimulator - HeadacheNeurology2
QAKNon-Invasive Vagus Nerve Stimulator For Migraine HeadacheNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815203022786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815203022786008152030227868152030227860815203022786

GMDN Terms#

Term, Definition table
TermDefinition
Migraine-therapy peripheral nerve electrical stimulatorA 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.

Contacts#

Phone, Email table
PhoneEmail
1-888-903-2673customerservice@electrocore.com

Regulatory Flags#

DUNS number
831341628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815203022762gmmaCore - Refill Card12116-00501-C12116-00501-C2026-06-25
00815203022779gammaCore Refill Card12116-00503-C2026-06-25
00815203020089gammaCore Sapphire20016-00301-RPL20016-00301-RPL2026-02-16
00815203021864gammaCore Sapphire20016-00501-RPL20016-00501-RPL2026-02-16
00815203022045gammaCore Sapphire 13016-04501-C13016-04501-C2026-02-16
00815203022052gammaCore Sapphire13016-04502-C13016-04502-C2026-02-16
00815203022076gammaCore Sapphire13016-04504-C13016-04504-C2026-02-16
00815203022236gammaCore Sapphire12016-0499912016-049992026-02-16
00815203022441gammaCore20016-00003-RPL20016-00003-RPL2026-02-16
00815203022458gammaCore20016-00006-RPL20016-00006-RPL2026-02-16
00815203022687gammaCore Sapphire20016-00502-RPL20016-00502-RPL2026-02-16
00815203022694gammaCore Emerald20116-00001-RPL20116-00001-RPL2026-02-16
00815203022700gammaCore Emerald20116-10301-RPL20116-10301-RPL2026-02-16
00815203022717gammaCore Emerald50022-00004-RPL50022-00004-RPL2026-02-16
00815203022724gammaCore Emerald50022-00078-RPL50022-00078-RPL2026-02-16
00815203022427gammaCore Sapphire AC Power Adapter20016-00001-RPL20016-00001-RPL2026-01-28
00815203022472gammaCore Emerald 3-Month Device Kit12116-0400312116-040032026-01-14
00815203022489gammaCore Emerald 12-Month Device Kit12116-0401212116-040122026-01-14
00815203022496gammaCore Emerald-D Device Kit12116-0403612116-040362026-01-14
00815203022502gammaCore Emerald 6-Month Evaluation Device Kit11116-0400611116-040062026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815203022762gmmaCore - Refill CardelectroCore, Inc.PKR2026-06-25
00815203022762gmmaCore - Refill CardelectroCore, Inc.QAK2026-06-25
00815203022779gammaCore Refill CardelectroCore, Inc.QAK2026-06-25
00815203022779gammaCore Refill CardelectroCore, Inc.PKR2026-06-25
00815203020089gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203020089gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203021864gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203021864gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022045gammaCore Sapphire electroCore, Inc.QAK2026-02-16
00815203022045gammaCore Sapphire electroCore, Inc.PKR2026-02-16
00815203022052gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022052gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203022076gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022076gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203022236gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022236gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203022441gammaCoreelectroCore, Inc.QAK2026-02-16
00815203022441gammaCoreelectroCore, Inc.PKR2026-02-16
00815203022458gammaCoreelectroCore, Inc.PKR2026-02-16
00815203022458gammaCoreelectroCore, Inc.QAK2026-02-16
00815203022687gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203022687gammaCore SapphireelectroCore, Inc.QAK2026-02-16
00815203022694gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022694gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022700gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022700gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022717gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022717gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022724gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022724gammaCore EmeraldelectroCore, Inc.QAK2026-02-16