gammaCore Refill Card 10-Day
Basic Information
- Brand Name
- gammaCore Refill Card 10-Day
- Primary DI
- 00815203020041
- Version / Model
- 10016-43110
- Catalog Number
- 10016-43110
- Company Name
- ELECTROCORE, LLC
- Labeler DUNS
- 831341628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-06
- Public Version
- 3
- Public Version Date
- 2020-05-21
- Public Version Status
- Update
- Public Device Record Key
- 35c15168-1cd2-4d10-b089-815a6f66bd26
Device Description
Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a "gammaCore Refill Card" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away.
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 | 00815203020041 | GS1 |
Customer Contacts
- Phone
- 1-888-903-2673
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not bend or fold the Refill Card
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 38 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 38 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- – 80 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- – 80 KiloPascal