Genius 2 989803179611

GUDID 20884838028726

Philips Medical Systems

Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID20884838028726
NIH Device Record Keyd1339aff-3b8e-453b-bab4-7094c80968be
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenius 2
Version Model Number989803179611
Catalog Number989803179611
Company DUNS078628040
Company NamePhilips Medical Systems
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS120884838028726 [Primary]

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-06
Device Publish Date2016-10-05

On-Brand Devices [Genius 2]

00884838030497989803180831
20884838028726989803179611
20884838028719989803179381

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