MR Patient Care Wireless SpO2 3.0 Module (Networks 1-5) 989803192771

GUDID 00884838111448

3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 1-5).

Philips Medizin Systeme Böblingen GmbH

Patient monitoring system module, pulse oximetry

• Primary Device ID: 00884838111448
• NIH Device Record Key: 4bdb6e3c-d141-41a6-b4d4-9d4ba6df1ca3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Patient Care Wireless SpO2 3.0 Module (Networks 1-5)
• Version Model Number: Wireless SpO2 3.0 Module (Networks 1-5)
• Catalog Number: 989803192771
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 708 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 70.8 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 531 Millimeter of Mercury and 765 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838111448 [Primary]

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-10
• Device Publish Date: 2025-06-02

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