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 |