FDA UDI
In Commercial Distribution
🇺🇸 United States
gammaCore Sapphire DEMO Refill Card Kit
DI: 00815203021802
·
Model: 14016-04504
·
ELECTROCORE, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- gammaCore Sapphire DEMO Refill Card Kit
- Primary DI
- 00815203021802
- Version / Model
- 14016-04504
- Catalog Number
- 14016-04504
- Company Name
- ELECTROCORE, LLC
- Labeler DUNS
- 831341628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-04
- Public Version
- 1
- Public Version Date
- 2021-08-12
- Public Version Status
- New
- Public Device Record Key
- 267540d3-fbd3-404a-995d-215461899298
Device Description
gammaCore Sapphire R 93-Day DEMO Refill Card Kit intended to be used to refill / reload the gammaCore Sapphire R DEMO device for a specified number of days or months and doses so it can continue 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache | Neurology | 882.5892 | 2 |
| QAK | Non-Invasive Vagus Nerve Stimulator For Migraine Headache | Neurology | 882.5892 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58832 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815203021802 | GS1 |
Customer Contacts
- Phone
- 1-888-903-2673
- [email protected]
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- – 80 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- – 80 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 38 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 38 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not bend or fold the Refill Card