MR Patient Care Expression Model MR400 MRI Patient Monitoring System

Basic Information

• Brand Name: MR Patient Care Expression Model MR400 MRI Patient Monitoring System
• Primary DI: 00884838111363
• Version / Model: Expression MR400 MRI Patient Monitor Sys
• Catalog Number: 866185
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Labeler DUNS: 314101143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-02
• Public Version: 2
• Public Version Date: 2025-07-15
• Public Version Status: Update
• Public Device Record Key: a50f83e3-f766-4b52-96ca-7375478dc484

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838111363	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 122 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 5 – 80 Percent (%) Relative Humidity