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FDA UDI In Commercial Distribution 🇺🇸 United States

MR Patient Care Wireless SpO2 3.0 Module (Networks 1-5)

DI: 00884838111448 · Model: Wireless SpO2 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 SpO2 3.0 Module (Networks 1-5)
Primary DI: 00884838111448
Version / Model: Wireless SpO2 3.0 Module (Networks 1-5)
Catalog Number: 989803192771
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: 4bdb6e3c-d141-41a6-b4d4-9d4ba6df1ca3

Device Description

3rd-Generation wireless SpO2 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
36554	Patient monitoring system module, pulse oximetry	A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. 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 pulse oximetry parameters provided by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838111448	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