FDA.reportPublic FDA data

gammaCore Sapphire SLC DEMO Device Kit

Primary DI
00815203021314
Brand
gammaCore Sapphire SLC DEMO Device Kit
Company
electroCore, Inc.
Model
13016-04006
Catalog number
13016-04006
Device description
gammaCore Sapphire 62-Day DEMO Device Kit (preprogrammed, refillable) is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.
Published
2021-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
00815203021314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815203021314008152030213148152030213140815203021314

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0 KiloPascal80 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius38 Degrees Celsius
Special Storage Condition, Specify00Do not bend or fold the Refill Card
Storage Environment Atmospheric Pressure0 KiloPascal80 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius38 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

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 DIBrandModelCatalogPublished
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
00815203022519gammaCore 1-Month Refill Kit12116-0450112116-045012026-01-14
00815203022526gammaCore 3-Month Refill Kit12116-0450312116-045032026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815203020089gammaCore SapphireelectroCore, Inc.PKR2026-02-16
00815203020089gammaCore SapphireelectroCore, Inc.QAK2026-02-16
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.PKR2026-02-16
00815203022700gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022717gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022717gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022724gammaCore EmeraldelectroCore, Inc.PKR2026-02-16
00815203022724gammaCore EmeraldelectroCore, Inc.QAK2026-02-16
00815203022427gammaCore Sapphire AC Power AdapterelectroCore, Inc.QAK2026-01-28
00815203022427gammaCore Sapphire AC Power AdapterelectroCore, Inc.PKR2026-01-28
00815203022472gammaCore Emerald 3-Month Device KitelectroCore, Inc.QAK2026-01-14
00815203022472gammaCore Emerald 3-Month Device KitelectroCore, Inc.PKR2026-01-14