MR Patient Care Neonatal ECG 3.0 Cable IEC 989803193771

GUDID 00884838121171

ECG lead cable designed for use with 3rd-generation wireless ECG module and Neonatal Quadtrodes (IEC coded leads.)

Philips Medizin Systeme Böblingen GmbH

Electrocardiographic lead set, reusable

• Primary Device ID: 00884838121171
• NIH Device Record Key: 07198252-8359-4dbb-a9c7-89924b64ad5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Patient Care Neonatal ECG 3.0 Cable IEC
• Version Model Number: Neonatal ECG 3.0 Cable IEC
• Catalog Number: 989803193771
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838121171 [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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