BIS Bilateral Sensor

Lot numbers: 0528111A, 0603111A, 0604111A, 0606111A, 0607111A, 0608111A, 0609111A, 0615111A, 0620111A, 0621111A, 0624111A, 0625111A, 0627111A, 0701111A, 0707111A, 0712111A, 0713111A, 0725111A, 0726111A, 0726111B, 0727111A, 0727111B, 0728111A, 0728111B, 0729111A, 0729111B, 0801111A, 0808111A, 0809111A, 0810111A, 0811111A, 0812111A, 0813111A, 0814111A, 0820111A, 0821111A, 0822111A, 0822111B, 0823111A, 0823111B, 0824111A, 0824111B, 0825111A, 0825111B, 0826111A, 0826111B, 0921111A, 0923111A, 0923111B, 0924111A, 0926111A, 0927111A, 0930111A, 1001111A, 1003111A, 1004111A, 1005111A, 1006111A.

Neurological Devices

2

No

Nationwide Distribution (USA) including the states of: AZ, CA, CO, FL, GA, IL, KY, KS, LA, MA, MO, MS, NC, NM, NY, OH, PA, SD, TN, TX, UT, VA, WA, WI, WV and WY.

BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. || Product Usage: || To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.

Model Catalog: 186-0212 (Lot serial: 0607111A)

Neurological Devices

BIS BILATERAL SENSOR

BIS Bilateral Sensors