BIS

GUDID 10884521808270

BIS (TM) Advance Monitor

Covidien LP

Anaesthesia depth monitor

• Primary Device ID: 10884521808270
• NIH Device Record Key: 8ca9b474-78f7-4591-adc5-9814bf4da338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIS
• Version Model Number: PMB4000
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 54 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521808270 [Primary]

FDA Product Code

• OLW: Index-generating electroencephalograph software

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: 2024-05-06
• Device Publish Date: 2024-04-28

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