AccessGUDID - DEVICE: Nerivio Infinity Refill (07290017578200)

GUDID

Device Identifier (DI) Information

Brand Name: Nerivio Infinity Refill
Version or Model: FGD000110
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Theranica Bio-Electronics Ltd.

Primary DI Number: 07290017578200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532352807 *Terms of Use

Device Description: The Nerivio Infinity Reffil t is a disposable and replaceable unit. It connects to the Nerivio Infinity device by two metal pins located on the inner side of the unit that fit the sockets on the device. The outer side of the unit comes in contact with the skin and transfers the electrical current from the device to the body during the treatment. The refill unit is sufficient for up to 18 treatments of 45 minutes each. The Nerivio Infinity refill unit is equipped with a Near-Field Communication (NFC) chip, to ensure control and authenticity.

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):	No
Over the Counter (OTC):	Yes
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?
60682	Craniofacial analgesia electrical stimulator	A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGT	Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

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
Storage Environment Temperature: between 50 and 80.6 Degrees Fahrenheit
Storage Environment Humidity: between 40 and 60 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5eb70457-1bfd-4f3f-a3c5-5c192fce7c58
Public Version Date: November 25, 2024
Public Version Number: 3
DI Record Publish Date: November 20, 2023