AccessGUDID - DEVICE: gammaCore Refill Card 31-Day (00815203020058)

GUDID

Device Identifier (DI) Information

Brand Name: gammaCore Refill Card 31-Day
Version or Model: 10016-43131
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10016-43131
Company Name: ELECTROCORE, LLC

Primary DI Number: 00815203020058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831341628 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKR	Non-Invasive Vagus Nerve Stimulator - Headache
QAK	Non-Invasive Vagus Nerve Stimulator For Migraine Headache

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: less than 80 KiloPascal
Storage Environment Atmospheric Pressure: less than 80 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 38 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 38 Degrees Celsius
Special Storage Condition, Specify: Do not bend or fold the Refill Card

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd526254-822b-42fa-b61f-7143fccdc8f7
Public Version Date: May 21, 2020
Public Version Number: 3
DI Record Publish Date: April 06, 2018