MR Patient Care Universal Gating Interface 989803195521

GUDID 00884838088016

Gating cable for use between any Expression MR patient monitor and any wired or wireless MRI system accessories.

Philips Medizin Systeme Böblingen GmbH

MRI system synchronizer
Primary Device ID00884838088016
NIH Device Record Key249d68e8-348a-4d88-ab2d-32b0db2ec2d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Patient Care Universal Gating Interface
Version Model NumberUniversal Gating Interface
Catalog Number989803195521
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 Batchtrue
Serial Numberfalse
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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838088016 [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 Date2025-05-26
Device Publish Date2025-05-16

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00884838111431 - MR Patient Care Wireless ECG 3.0 Module (Networks 1-5)2025-06-10 3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 1-5).
00884838111448 - MR Patient Care Wireless SpO2 3.0 Module (Networks 1-5)2025-06-10 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 1-5).
00884838111455 - MR Patient Care Wireless SpO2 3.0 Module (Networks 6-10)2025-06-10 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 6-10).
00884838111462 - MR Patient Care Wireless ECG 3.0 Module (Networks 6-10)2025-06-10 3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 6-10).
00884838111370 - MR Patient Care SpO2 Sensor2025-06-09 Fiber Optic SpO2 Sensor for use with Wireless SpO2 3.0 Module (Networks 1-5) 989803192771 and SpO2 Clips and Grips accessories
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