MR Patient Care Long Wide ECG 2.0 Cable AAMI 989803170121

GUDID 00884838120693

ECG Leadwire Set designed for use with the Expression MRI Patient Monitor when utlizing the system's Advanced ECG Gradient Filter. Compatible with the CV Quadtrode 9371A.

Philips Medizin Systeme Böblingen GmbH

Electrocardiographic lead set, reusable

• Primary Device ID: 00884838120693
• NIH Device Record Key: ec29c128-5db3-4d7c-8938-98bf4521b0db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Patient Care Long Wide ECG 2.0 Cable AAMI
• Version Model Number: Long Wide ECG 2.0 Cable AAMI
• Catalog Number: 989803170121
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Device Count: 1
• DM Exempt: false
• 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: true
• Serial Number: false
• 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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 570 millibar and 1020 millibar
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 102 KiloPascal
• Storage Environment Atmospheric Pressure: Between 429 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	00884838120693 [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: 2025-05-28
• Device Publish Date: 2025-05-20

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