Home GUDID 20884521810102 INVOS
Primary DI 20884521810102
Brand INVOS
Company Covidien LP
Model PM7100
Device description PM7100 Patient Monitor
Published 2021-06-14
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false 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 20884521810102 Package GS1 4 In Commercial Distribution 10884521810105 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521810102 20884521810102 10884521810105 10884521810105
GMDN Terms# Term, Definition table Term Definition Cerebral oximeter A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. It uses a cerebral sensor(s) having a light source and photodiode detector that is/are placed on the scalp/head. Position-1 detector detects infrared light absorption of extracranial blood and position-2 detector detects infrared light absorption of cerebral blood. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2.
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 0.465 KiloPascal 1.075 KiloPascal Handling Environment Atmospheric Pressure 0.616 KiloPascal 1.075 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 -4 Degrees Fahrenheit 113 Degrees Fahrenheit Handling Environment Temperature 50 Degrees Fahrenheit 95 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Fragile, Keep dry Storage Environment Atmospheric Pressure 0.047 KiloPascal 0.108 KiloPascal Storage Environment Atmospheric Pressure 0.616 KiloPascal 1.075 KiloPascal Storage Environment Atmospheric Pressure 47 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 -4 Degrees Fahrenheit 113 Degrees Fahrenheit Storage Environment Temperature 50 Degrees Fahrenheit 95 Degrees Fahrenheit
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 false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
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