MR Patient Care Wireless SpO2 3.0 Module (Networks 1-5) 989803192771

GUDID 00884838111448

3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 1-5).

Philips Medizin Systeme Böblingen GmbH

Patient monitoring system module, pulse oximetry
Primary Device ID00884838111448
NIH Device Record Key4bdb6e3c-d141-41a6-b4d4-9d4ba6df1ca3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Patient Care Wireless SpO2 3.0 Module (Networks 1-5)
Version Model NumberWireless SpO2 3.0 Module (Networks 1-5)
Catalog Number989803192771
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 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 708 millibar and 1020 millibar
Storage Environment Atmospheric PressureBetween 70.8 KiloPascal and 102 KiloPascal
Storage Environment Atmospheric PressureBetween 531 Millimeter of Mercury and 765 Millimeter of Mercury
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838111448 [Primary]

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-10
Device Publish Date2025-06-02

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