AccessGUDID - DEVICE: gammaCore Sapphire Refill Card Kit (00815203021796)

GUDID

Device Identifier (DI) Information

Brand Name: gammaCore Sapphire Refill Card Kit
Version or Model: 14016-04503
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14016-04503
Company Name: ELECTROCORE, LLC

Primary DI Number: 00815203021796
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831341628 *Terms of Use

Device Description: gammaCore Sapphire R 12-Month Refill Card Kit intended for use with gammaCore Sapphire R Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

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: 9f778845-52c1-4785-a0d2-3200fdf75e1c
Public Version Date: August 12, 2021
Public Version Number: 1
DI Record Publish Date: August 04, 2021