Nerivio
GUDID 07290017578026
Refill pack for Nerivio device
Theranica Bio-Electronics Ltd.
Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator| Primary Device ID | 07290017578026 |
| NIH Device Record Key | 0fba07f1-db7d-4e1b-aa15-1b5fbeb483e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nerivio |
| Version Model Number | FGD000075 |
| Company DUNS | 532352807 |
| Company Name | Theranica Bio-Electronics Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com | |
| Phone | (937) 637-4846 |
| support@nerivio.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017578026 [Primary] |
FDA Product Code
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-18 |
| Device Publish Date | 2022-01-10 |
On-Brand Devices [Nerivio]
| 07290017578019 | Nerivio is a wireless remote electrical neuromodulation device for the acute treatment of migrai |
| 07290017578026 | Refill pack for Nerivio device |
Trademark Results [Nerivio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NERIVIO 79270961 not registered Live/Pending |
THERANICA BIO-ELECTRONICS LTD. 2019-08-06 |
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