Home GUDID 20884521818979 Nellcor OxySoft
Primary DI 20884521818979
Brand Nellcor OxySoft
Company Covidien LP
Model OxySoftN
Device description Neonatal-Adult SpO2 Sensor;OxiMax TM Technology
Published 2022-08-15
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile 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 20884521818979 Package GS1 24 In Commercial Distribution 10884521818972 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521818979 20884521818979 10884521818972 10884521818972
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0.5 KiloPascal 1.06 KiloPascal Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Atmospheric Pressure 62 KiloPascal 106 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature -40 Degrees Celsius 70 Degrees Celsius Handling Environment Temperature 0 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 Keep dry Storage Environment Atmospheric Pressure 0.62 KiloPascal 1.06 KiloPascal Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Atmospheric Pressure 62 KiloPascal 106 KiloPascal Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 70 Degrees Celsius Storage Environment Temperature 0 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 058614483 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# 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
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