Expression MRI Patient Monitoring System (Model 865214)

Basic Information

• Brand Name: Expression MRI Patient Monitoring System (Model 865214)
• Primary DI: 00884838016064
• Version / Model: Expression MRI Patient Monitor
• Catalog Number: 865214
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 10
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 3234df41-48ec-489f-a225-ac5547692959
• Distribution End Date: 2021-12-31

Device Description

Expression MRI Patient Vital Signs Monitor, Wireless 2.4 GHz Dual Lead ECG Capable, Wireless 2.4 GHz, Pulse Oximetry (SpO2) Capable, Integrated Non-Invasive Blood Pressure (NIBP), Advanced ECG Filter, Integrated End-Tidal CO2, Active Trend Arrows, 360 Degree Alarm light, Quick Connect Accessories, All parameters support Adult, Pediatric, Infant and Neonatal applications, 8-Hour Smart Battery Technology, One (1) year limited warranty and factory service for hardware, Patient Monitor manufactured by Philips Healthcare and branded for Invivo Corporation, anaffiliate of Philips Healthcare. The Patient Monitor is provided with Invivo's standard 1 year. Warranty,a copy of which is available upon request. Post warranty service may be purchased for the Invivo Patient Monitor at the point of sale. For service after the point-of-sale, please contact. Invivo at 1-877-468-4861 option 1, option 3.

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: No
• 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	00884838016064	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]