| Primary Device ID | 00815203022465 |
| NIH Device Record Key | 7dcf7927-2d69-44e5-b7dc-3a0704fe8dde |
| Commercial Distribution Discontinuation | 2025-09-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | gammaCore Emerald 1-Month Device Kit |
| Version Model Number | 12116-04001 |
| Catalog Number | 12116-04001 |
| 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 |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com | |
| Phone | 1-888-903-2673 |
| customerservice@electrocore.com |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815203022465 [Primary] |
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-15 |
| Device Publish Date | 2025-09-05 |
| 00815203022465 - gammaCore Emerald 1-Month Device Kit | 2025-09-151-Month Device Kit |
| 00815203022465 - gammaCore Emerald 1-Month Device Kit | 2025-09-15 1-Month Device Kit |
| 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 |