| Primary Device ID | B426OXY2DUR10 | 
| NIH Device Record Key | 3d05a704-bf2e-4153-b384-a550593483d7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Intra.Ox Smart Sensor | 
| Version Model Number | OXY2-DUR-1 | 
| Catalog Number | OXY-2-DUR-1 | 
| Company DUNS | 127211923 | 
| Company Name | VIOPTIX, INC. | 
| 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 | true | 
| Expiration Date | false | 
| 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 | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | |
| Phone | 510-226-5860 | 
| info@vioptix.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B426OXY2DUR10 [Primary] | 
| MUD | Oximeter, Tissue Saturation | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-04-27 | 
| Device Publish Date | 2020-04-17 | 
| B426OXY2DUR10 - Intra.Ox Smart Sensor | 2020-04-27 | 
| 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 | 
| B426OXY2SPI10 - T.Ox SS Sensor | 2018-07-06 |