BIS 186-0212-PH

GUDID 90884521548387

PHILIPS BILATERAL SENSOR KIT

Covidien LP

Cerebral oximeter sensor, single-use

• Primary Device ID: 90884521548387
• NIH Device Record Key: e23aafd3-4958-47e6-94fc-cbf2beed7ec0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIS
• Version Model Number: 186-0212-PH
• Catalog Number: 186-0212-PH
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521548381 [Primary]
GS1	30884521657865 [Unit of Use]
GS1	90884521548387 [Package]; Contains: 10884521548381; Package: CASE [9999 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143506

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-09-19

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• 10884521812369: BISX4 Module Refurbished, Software Version 1.15; For use with Nihon Kohden Monitors
• 10884521533110: BISX Module
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• 10884521533073: BISX4 Module Software Version 1.15; For use with Nihon Kohden Monitors
• 10884521134478: Bilateral Sensor For use with BIS Monitoring Systems
• 10884521702868: BIS LoC 2 Channel, Refurbished, Software Version 1.13 For use with Philips Patient Monitors
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• 10884521553170: BIS LoC 4 Channel Refurbished, Software Version 1.15. For use with Philips Patient Monitors
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• 10884521170230: BISX Module,Refurbished, Software Version 1.15,For use with BIS Monitors
• 10884521170223: 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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• 10884521130180: BISX4 Module,Refurbished
• 10884521130173: Monitoring System,Refurbished
• 10884521130098: BISX Module,Software Version 1.13,For use with Philips Patient Monitors
• 10884521130074: BISX Module,Software Version 1.13,For use with Spacelabs Healthcare Patient Monitors
• 10884521129832: BISX Module,Software Version 1.15,For use with BIS Complete Monitors
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