Nerivio
GUDID 07290017578026
Refill pack for Nerivio device
Theranica Bio-Electronics Ltd.
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 | |
| 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 |
| 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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