gammaCore Emerald 1-Month Device Kit 12116-04001

GUDID 00815203022465

1-Month Device Kit

ELECTROCORE, LLC

Migraine-therapy peripheral nerve electrical stimulator
Primary Device ID00815203022465
NIH Device Record Key7dcf7927-2d69-44e5-b7dc-3a0704fe8dde
Commercial Distribution Discontinuation2025-09-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NamegammaCore Emerald 1-Month Device Kit
Version Model Number12116-04001
Catalog Number12116-04001
Company DUNS831341628
Company NameELECTROCORE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com
Phone1-888-903-2673
Emailcustomerservice@electrocore.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100815203022465 [Primary]

FDA Product Code

PKRNon-Invasive Vagus Nerve Stimulator - Headache

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-15
Device Publish Date2025-09-05

Devices Manufactured by ELECTROCORE, LLC

00815203022465 - gammaCore Emerald 1-Month Device Kit2025-09-151-Month Device Kit
00815203022465 - gammaCore Emerald 1-Month Device Kit2025-09-15 1-Month Device Kit
00815203020539 - gammaCore Sapphire SLC Device Kit2021-08-12 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 Kit2021-08-12 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 Kit2021-08-12 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 Kit2021-08-12 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 Kit2021-08-12 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 Kit2021-08-12 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 Kit2021-08-12 gammaCore Sapphire 93-Day Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck

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