BIS

GUDID 10884521130197

BISX4 Module,Software Version 1.13

Covidien LP

Anaesthesia depth monitor

• Primary Device ID: 10884521130197
• NIH Device Record Key: 12e8d2b7-0fc0-445a-8449-89d28530e08b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIS
• Version Model Number: 186-0224-MR
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;This side up;Fragile
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521130197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072286

FDA Product Code

• OLW: Index-generating electroencephalograph software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-08
• Device Publish Date: 2016-10-13

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• 10884521175501: OEM A2000 Simulator Demo,Refurbished
• 10884521170278: Monitoring System
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• 10884521170230: BISX Module,Refurbished, Software Version 1.15,For use with BIS Monitors
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• 10884521157538: Monitoring System,Refurbished
• 10884521130265: BISX Module,Refurbished, Software Version 1.13
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