Expression MR Wireless ECG Patient Module (Gen 3) 6-10

Basic Information

• Brand Name: Expression MR Wireless ECG Patient Module (Gen 3) 6-10
• Primary DI: 00884838055018
• Version / Model: Wireless ECG 3.0 Module (Networks 6-10)
• Catalog Number: 989803194341
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 8
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 6924338d-fe8b-40f4-9a94-6eb8b26c745a

Device Description

3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 6-10).

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
36349	Patient monitoring system module, electrocardiographic	A small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838055018	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 708 – 1020 millibar
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70.8 – 102 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 531 – 765 Millimeter of Mercury