T.Ox SS Sensor OXY-2-SPI-1

GUDID B426OXY2SPI10

VIOPTIX, INC.

Tissue saturation oximeter sensor, single-use
Primary Device IDB426OXY2SPI10
NIH Device Record Key37cf4de0-5c3f-41cd-8bf4-1b76900644f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameT.Ox SS Sensor
Version Model NumberOXY2-SPI-1
Catalog NumberOXY-2-SPI-1
Company DUNS127211923
Company NameVIOPTIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB426OXY2SPI10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUDOximeter, Tissue Saturation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

Devices Manufactured by VIOPTIX, INC.

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
B426OXY2SPI10 - T.Ox SS Sensor2018-07-06

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