| Primary Device ID | 00851221006452 |
| NIH Device Record Key | 3028cc81-028d-4ba1-9785-b3794da12de9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUELL 2.0 |
| Version Model Number | QE-NAR |
| Company DUNS | 957536014 |
| Company Name | NEUROMETRIX, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | true |
| Phone | 781-314-2781 |
| rainer_maas@neurometrix.com |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851221006452 [Primary] |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2018-09-17 |
| 00851221006483 | Amazon Quell 2.0 Device Box (includes device, 1 electrode with UDI 00851221006018 and/or UDI 008 |
| 00851221006469 | Consumer Starter Kit, eCommerce (includes device, 1 pack electrode with UDI 00851221006018, 1 ch |
| 00851221006452 | Retailer Quell 2.0 Device Box (includes device, 1 electrode with UDI 00851221006018 or UDI 00851 |
| 00851221006803 | Quell 2.0 Relief Replacement Device (OTC) |
| 00851221006742 | Large Band for 2.0 Device |
| 00851221006735 | Small Band for 2.0 Device |