Device Dossier
Probe, pulse oximeter, single use
Device Dossier for Probe, pulse oximeter, single use (Probe, pulse oximeter, single use, Class IIb, sponsor Stryker). ARTG record, intended purpose, GMDN…
- GMDN category: Probe, pulse oximeter, single use
- Sponsor: Stryker
Intended purpose
Adult, Pediatric, Infant, Neonatal and Preterm adhesive sensors are indicated for single patient use for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor) &/or arterial carboxyhemoglobin saturation (SpCO) and arterial methemoglobin (SpMet)for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. The main single use pulse oximetry sensor is intended for use with LIFEPAK monitor/defibrillators.