DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES

Primary DI

M9831209000011

Basic UDI-DI Code

B-M9831209000011

Reference

OS-VO100, SEN-VO100

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Mespere LifeSciences Inc

OS-VO100: Mespere Display Software can be loaded to a tablet, laptop, or stationary PC. The SjvO2, BVI, and JVDindex trend data is displayed on the computer, with the x axis representing number of data points and the y axis displaying the history SjvO2, BVI, and JVDindex trend data. The current version of the Venous Oximetry System does not allow the user to display the SjvO2, BVI, and JVDindex trend data in another unit. • SEN-VO100: VO100 sensor that detects signal, transmits and collects data, performs calculation, and transmits from the sensor to the display monitor. Used to get the venous oxygen saturation and blood volume index determined from the jugular vein and corresponding plethymographic waveform. • SA-VO100: VO100 sensor adhesive is used to adhere the sensor to the patient’s skin. The adhesive is single use and medical grade. The material is 3M #9874 Medical double coated tape which complies with the ISO10993-1:2009 “Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process” standard. Please refer to the biocompatibility report for more information. • IS-O1: An isolation device provides electrical isolation between the computer and the VO 100 sensor

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).