989803205831

GUDID 20884838102655

Philips Medizin Systeme Böblingen GmbH

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Primary Device ID20884838102655
NIH Device Record Key386d4484-2ff0-4ee6-b012-ffc5d7b3e61e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803205831
Catalog Number989803205831
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
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Phone+1(999)999-9999
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Phone+1(999)999-9999
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Emailxx@xx.xx
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Phone+1(999)999-9999
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Phone+1(999)999-9999
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Emailxx@xx.xx
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Emailxx@xx.xx
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Emailxx@xx.xx
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Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
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Emailxx@xx.xx
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Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 12 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 53.6 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 18 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838102651 [Unit of Use]
GS120884838102655 [Primary]

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-26
Device Publish Date2021-03-18

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00884838102705 - NA2021-11-04
00884838102699 - NA2021-11-02

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