Home GUDID 10884521809789 INVOS
Primary DI 10884521809789
Brand INVOS
Company Covidien LP
Model PMSENS71-P
Device description Pediatric rSO2 Sensor
Published 2021-06-19
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MUD Oximeter, tissue saturation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MUD Oximeter, Tissue Saturation Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10884521809789 Package GS1 5 In Commercial Distribution 20884521809786 Package GS1 10 In Commercial Distribution 30884521809783 Package GS1 20 In Commercial Distribution 10884521807433 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10884521809789 10884521809789 20884521809786 20884521809786 30884521809783 30884521809783 10884521807433 10884521807433
GMDN Terms# Term, Definition table Term Definition Cerebral oximeter sensor, single-use A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 47 KiloPascal 108 KiloPascal Handling Environment Atmospheric Pressure 62 KiloPascal 108 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 30 Degrees Celsius Handling Environment Temperature 10 Degrees Celsius 35 Degrees Celsius Special Storage Condition, Specify 0 0 Do not immerse in any liquids, Transport Temp -10 deg. C to 50 deg. C up to 72 hours Storage Environment Atmospheric Pressure 47 KiloPascal 108 KiloPascal Storage Environment Atmospheric Pressure 62 KiloPascal 108 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 10 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 058614483 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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# 
covidien.com