MR Patient Care Expression Model MR400 MRI Patient Monitoring System 866185

GUDID 00884838111363

Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smart Battery Technology, 3rd-Gen Wireless ECG with Advanced Filters, 3rd-Gen Wireless Pulse Oximetry (SpO2) with Perfusion Index, Single-Lumen Non-Invasive Blood Pressure (NIBP), CO2 monitoring with Respiration Rate, Wired and wireless gating with MRI systems, and Multi-priority alarm system with CDS. All parameters support Adult, Pediatric, Infant and Neonatal applications. One (1) day on-site Expression system training, One (1) year limited warranty and factory service for hardware.

Philips Medizin Systeme Böblingen GmbH

General-purpose multi-parameter bedside monitor

• Primary Device ID: 00884838111363
• NIH Device Record Key: a50f83e3-f766-4b52-96ca-7375478dc484
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Patient Care Expression Model MR400 MRI Patient Monitoring System
• Version Model Number: Expression MR400 MRI Patient Monitor Sys
• Catalog Number: 866185
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838111363 [Primary]

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-10
• Device Publish Date: 2025-06-02

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838111363 - MR Patient Care Expression Model MR400 MRI Patient Monitoring System: 2025-06-10Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smart Battery Technology, 3rd-Gen Wireless ECG with Advanced Filters, 3rd-Gen Wireless Pulse Oximetry (SpO2) with Perfusion Index, Single-Lumen Non-Invasive Blood Pressure (NIBP), CO2 monitoring with Respiration Rate, Wired and wireless gating with MRI systems, and Multi-priority alarm system with CDS. All parameters support Adult, Pediatric, Infant and Neonatal applications. One (1) day on-site Expression system training, One (1) year limited warranty and factory service for hardware.
• 00884838111363 - MR Patient Care Expression Model MR400 MRI Patient Monitoring System: 2025-06-10 Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smar
• 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 Sensor: 2025-06-09 Fiber Optic SpO2 Sensor for use with Wireless SpO2 3.0 Module (Networks 1-5) 989803192771 and SpO2 Clips and Grips accessories
• 00884838111479 - MR Patient Care Temperature Sensor (Esophageal / Rectal / Axillary, Direct Mode): 2025-06-09 Temperature sensor for Expression MRI patient monitors, capable of surface measurement or, with applied FlexTEMP Jacket, esophog
• 00884838111400 - MR Patient Care Temperature Sensor Jacket: 2025-06-09 Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the Flex