Flexible SpO2 Sensor, Reusable - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

Flexible SpO2 Sensor, Reusable

UID: IMP/MD/2023/000190_94fec884d9c54c682edee36153008a3e_7078662565ca675e5316d0cd3c8fd63e

Brand Name

Nellcor

License Holder

India Medtronic Private Limited

Device Class

Class B

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.