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FDA UDI In Commercial Distribution 🇺🇸 United States

MR Patient Care Wireless ECG 3.0 Module (Networks 1-5)

DI: 00884838111431 · Model: Wireless ECG 3.0 Module (Networks 1-5) · Philips Medizin Systeme Böblingen GmbH

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: MR Patient Care Wireless ECG 3.0 Module (Networks 1-5)
Primary DI: 00884838111431
Version / Model: Wireless ECG 3.0 Module (Networks 1-5)
Catalog Number: 989803192761
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: 1
Public Version Date: 2025-06-10
Public Version Status: New
Public Device Record Key: afa25824-3991-4027-be68-992bb2a03e6c

Device Description

3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 1-5).

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
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	00884838111431	GS1

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
Type: Storage Environment Humidity
Temperature Range: 5 – 80 Percent (%) Relative Humidity