XHALE ASSURANCE, INC.

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Filters

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

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

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

Device Class :

Duns Number: 031138244

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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