Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Us ...



Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision
Components:
Recall Date:    May 8, 2019
Mfg:
Xhale Assurance, Inc.
Mfg Country:
United States
Recall ID:    82817
Product ID:    172753
Enforcement Date:    Aug 7, 2019
Last Published:    May 14, 2021

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Emert Number:    Z-2133-2019
Emert Status:    Updated