Intra.Ox Smart Sensor OXY-2-DUR-1

GUDID B426OXY2DUR10

VIOPTIX, INC.

Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use
Primary Device IDB426OXY2DUR10
NIH Device Record Key3d05a704-bf2e-4153-b384-a550593483d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntra.Ox Smart Sensor
Version Model NumberOXY2-DUR-1
Catalog NumberOXY-2-DUR-1
Company DUNS127211923
Company NameVIOPTIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com
Phone510-226-5860
Emailinfo@vioptix.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB426OXY2DUR10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUDOximeter, Tissue Saturation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-27
Device Publish Date2020-04-17

Devices Manufactured by VIOPTIX, INC.

B426OXY2DUR10 - Intra.Ox Smart Sensor2020-04-27
B426OXY2DUR10 - Intra.Ox Smart Sensor2020-04-27
B426OXY2QCT10 - Intra.Ox Optical QC Target2020-04-27
B426OXY2STH10 - Intra.Ox Disposable Sheath2020-04-27
B426OXY2SPD10 - T.Ox SP Sensor2018-07-06
B426OXY2SPI10 - T.Ox SS Sensor2018-07-06
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.