XHALE ASSURANCE, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Oximeter (DQA) (3)

Premarket Exempt

Clear

Nasal Alar Sp02 Sensor - B2130201A010 Catalog Number :

Device Description : The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for 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, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.The Assurance® Nasal Alar SpO2™ Sensor (REF 0201-A01) is for use with Philips FAST SpO2 compatible monitors.

Device Class : 2

Duns Number: 031138244

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nasal Alar Sp02 Sensor - B21303030 Catalog Number :

Device Description : The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for 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, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.

Device Class :

Duns Number: 031138244

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Nasal Alar Sp02 Sensor - B213301112140 Catalog Number :

Device Description : The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for 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, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.

Device Class :

Duns Number: 031138244

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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