| Primary Device ID | B426OXY2SPD10 |
| NIH Device Record Key | a796a55d-721b-42b9-8218-4224b472d299 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T.Ox SP Sensor |
| Version Model Number | OXY-2-SPD-1 |
| Catalog Number | OXY-2-SPD-1 |
| Company DUNS | 127211923 |
| Company Name | VIOPTIX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 510-226-5860 |
| info@vioptix.com | |
| Phone | 510-226-5860 |
| info@vioptix.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B426OXY2SPD10 [Primary] |
| MUD | Oximeter, Tissue Saturation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
| B426OXY2DUR10 - Intra.Ox Smart Sensor | 2020-04-27 |
| B426OXY2QCT10 - Intra.Ox Optical QC Target | 2020-04-27 |
| B426OXY2STH10 - Intra.Ox Disposable Sheath | 2020-04-27 |
| B426OXY2SPD10 - T.Ox SP Sensor | 2018-07-06 |
| B426OXY2SPD10 - T.Ox SP Sensor | 2018-07-06 |
| B426OXY2SPI10 - T.Ox SS Sensor | 2018-07-06 |