A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron…
A noninvasive device designed to continuously measure a patient’s tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron 1Xi PadSet via the ExSpiron 1Xi Patient Cable, the ExSpiron 1Xi Monitor provides a measurement of a patient’s respiratory parameters, while also incorporating alarms. The ExSpiron 1Xi Monitor can be integrated into a medical facility’s nurse call system via the ExSpiron 1Xi Nurse Call Module.
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for ExSpiron 1Xi | Listed by | Respiratory Motion, Inc., United States |
| FDA product code | BZK |
| Device type | Spirometer, Monitoring (W/Wo Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1850 |
| Record published | 2016-09-24 |
| Record revised | 2023-09-25 (version 6) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 20 to 80 % RH; Handling environment humidity 20 to 80 % RH; Storage environment temperature -20 to 65 °C; Handling environment temperature 5 to 32 °C |
| Packaging | Outer case |
| UDI direct marking | Exempt |
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.