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

Pulse oximeter probe, reusable

• 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

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