Flexible SpO2 Sensor, Reusable
- UID
- IMP/MD/2023/000190_94fec884d9c54c682edee36153008a3e_7078662565ca675e5316d0cd3c8fd63e
- Device class
- Class B
- Brand name
- Nellcor
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The Nellcor™ Flexible SpO2 Sensors, models FLEXMAX and FLEXMAX-P, are intended for use with monitoring systems that use OxiMax™ and Nellcor™ compatible pulse oximeters. The Nellcor™ Flexible SpO2 sensors are intended for use in non-invasive continuous or spotcheck monitoring of functional oxygen saturation of arterial hemoglobin (Nellcor) and pulse rate. The sensor size range includes a large and small sensor. The sensors are intended for use on adult and pediatric (Nellcor) patients weighing greater than 20kg. The use environment may include: hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport, and home use. Transport environments include intra-hospital transport and both ground and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The use environment is dependent upon the use environments specified for the monitoring system utilized in conjunction with the sensor. The Nellcor™ Flexible SpO2 Sensors are for prescription use only.
Flexible SpO2 Sensor, Reusable is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000190_94fec884d9c54c682edee36153008a3e_7078662565ca675e5316d0cd3c8fd63e. This device is marketed under the brand name Nellcor. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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