Nerivio

Primary DI
07290017578026
Brand
Nerivio
Company
Theranica Bio-Electronics Ltd.
Model
FGD000075
Device description
Refill pack for Nerivio device
Published
2022-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute MigraineNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017578026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017578026072900175780267290017578026

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial analgesia electrical stimulatorA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity40 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit80.6 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(937) 637-4846support@nerivio.com

Regulatory Flags#

DUNS number
532352807
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017578118Nerivio InfinityFGD000100FGD0001002024-06-20
07290017578101Nerivio InfinityFGD000100FGD0001002023-11-20
07290017578200Nerivio Infinity Refill FGD0001102023-11-20
07290017578019NerivioFGD0000752019-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017578118Nerivio InfinityTheranica Bio-Electronics Ltd.QGT2024-06-20
07290017578101Nerivio InfinityTheranica Bio-Electronics Ltd.QGT2023-11-20
07290017578200Nerivio Infinity Refill Theranica Bio-Electronics Ltd.QGT2023-11-20
07290017578019NerivioTheranica Bio-Electronics Ltd.QGT2019-09-10