Vios Monitoring System Pulse Oximetry Sensor L2050R

GUDID B595L2050R0

The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.

MURATA VIOS PRIVATE LIMITED

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Primary Device ID	B595L2050R0
NIH Device Record Key	bc012b67-d88e-449f-8b4c-2037bdb9f5e0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vios Monitoring System Pulse Oximetry Sensor
Version Model Number	L2050R Pulse Oximetry Sensor
Catalog Number	L2050R
Company DUNS	874148340
Company Name	MURATA VIOS PRIVATE LIMITED
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

Customer Support Contacts

Phone	866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com
Phone	+1-866-990-1434
Email	ViosSupport@murata.com

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B595L2050R0 [Primary]
HIBCC	B595L2050R1 [Package] Package: case [50 Units] In Commercial Distribution
HIBCC	B595L2050R2 [Package] Package: case [8 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172586

FDA Product Code

DQA

Oximeter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-05-05
Device Publish Date	2020-04-27

Devices Manufactured by MURATA VIOS PRIVATE LIMITED

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B595CSM20500 - Vios Monitoring System Central Station Monitor	2020-05-11 The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software is indicated for use by healthcare professionals for cen
B595VCS2050 - Vios Monitoring System Central Server	2020-05-11 The Vios Monitoring System (VMS) Central Server (CS) Software acts as the server relay for the VMS system. It transmits, stores,
B595VMM2050 - Vios Monitoring System Mobile Application	2020-05-11 The Vios Monitoring System (VMS) Mobile Application is indicated for use by healthcare professionals for centralized monitoring
B595L2050R0 - Vios Monitoring System Pulse Oximetry Sensor	2020-05-05The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
B595L2050R0 - Vios Monitoring System Pulse Oximetry Sensor	2020-05-05 The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiologica
B595CS20500 - Vios Monitoring System Chest Sensor	2020-04-10 The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiologica
B595L2050G0 - Vios Montioring System Adapter	2020-04-10 The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiologica