HSA · registration DE0507227Covidien Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor
- Registration number
- DE0507227
- Model name
- Nellcor™ OxySoft™ Neonatal-Adult SpO2; Nellcor™ OxySoft™ Neonatal-Adult SpO2
- Model identifier
- OxySoftN; OxySoftNHC
- Registration date
- September 01, 2022
- Source update date
- April 07, 2025
- Risk class
- Class C
- Product owner
- Covidien llc
- Registrant / registration holder
- COVIDIEN PRIVATE LIMITED
The Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor is intended for use in non-invasive continuous or spot-check monitoring of functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate for neonates and infants weighing less than 3 kg or adults and pediatrics weighing more than 40 kg. It is indicated for use during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra- hospital transport, mobile emergency medical applications including both ground and air transport and home environments.
- Product owner address
- 15 Hampshire Street Mansfield, MA 02048, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.