AccessGUDID - DEVICE: Nerivio (07290017578026)

GUDID

Device Identifier (DI) Information

Brand Name: Nerivio
Version or Model: FGD000075
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Theranica Bio-Electronics Ltd.

Primary DI Number: 07290017578026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532352807 *Terms of Use

Device Description: Refill pack for Nerivio device

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?
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 50 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: 0fba07f1-db7d-4e1b-aa15-1b5fbeb483e8
Public Version Date: October 21, 2024
Public Version Number: 3
DI Record Publish Date: January 10, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (937) 637-4846
Email: support@nerivio.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES