Home GUDID B21303030
Nasal Alar Sp02 Sensor
Primary DI B21303030
Brand Nasal Alar Sp02 Sensor
Company XHALE ASSURANCE, INC.
Model 0303
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 is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
Published 2017-02-11
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 B21303031 Package HIBCC 24 B21303032 Package HIBCC 6 In Commercial Distribution B21303030 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 B2130201A010 Nasal Alar Sp02 Sensor 0201-A01 2018-03-09 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04048675785910 Masimo SpO2 Module for Vista 300/S Shanghai Draeger Medical Instrument Co.,Ltd. DQA 2026-07-13 00010939962218 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 00093351041099 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 00845717013550 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 00845717013567 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 06972040113849 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 06972040113856 N/A Shenzhen AOJ Medical Technology Co., Ltd DQA 2026-07-11 06931973400563 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973400730 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973400785 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410326 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410333 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410340 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410364 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410371 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410388 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410395 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410401 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410418 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410425 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410432 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410449 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410456 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410647 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410678 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410685 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410692 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410715 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410722 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09 06931973410739 Caremed Shenzhen Caremed Medical Technology Co., Ltd. DQA 2026-07-09