Home GUDID B2130201A010 Nasal Alar Sp02 Sensor
Primary DI B2130201A010
Brand Nasal Alar Sp02 Sensor
Company XHALE ASSURANCE, INC.
Model 0201-A01
Device description 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.
Published 2018-03-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true
Product Codes# Code, Name table Code Name DQA Oximeter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQA Oximeter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B2130201A011 Package HIBCC 20 In Commercial Distribution B2130201A012 Package HIBCC 6 In Commercial Distribution B2130201A010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Pulse oximeter probe, single-use A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.
Regulatory Flags# DUNS number 031138244 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B21303030 Nasal Alar Sp02 Sensor 0303 2017-02-11 B213301112140 Nasal Alar Sp02 Sensor 301-11214 2017-03-17 B2130201A012 Nasal Alar Sp02 Sensor 0201-A01 2018-03-09 B21303031 Nasal Alar Sp02 Sensor 0303 2017-02-11
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