IntelliVue Bispectral Index (BIS) Module M1034B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. Bispectral Index (BIS) monitoring helps to monitor the level of…
IntelliVue Bispectral Index (BIS) Module M1034B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. Bispectral Index (BIS) monitoring helps to monitor the level of consciousness of a patient under general anesthesia or sedation in the OR and ICU.
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for BIS Module | Listed by | Philips Medizin Systeme Böblingen GmbH, Germany |
| FDA product code | OLW |
| Device type | Index-Generating Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Record published | 2016-12-13 |
| Record revised | 2024-12-20 (version 9) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment atmospheric pressure 57 to 106 KiloPascal; Storage environment humidity 15 to 90 % RH |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.