MR Patient Care Neonatal ECG Electrodes (25) 989803179051

GUDID 00884838117853

ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX

Philips Medizin Systeme Böblingen GmbH

Electrocardiographic electrode, single-use

• Primary Device ID: 00884838117853
• NIH Device Record Key: a6055f38-3890-4707-ac33-2377065bc517
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR Patient Care Neonatal ECG Electrodes (25)
• Version Model Number: Neonatal ECG Electrodes (25)
• Catalog Number: 989803179051
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Device Count: 25
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838117853 [Unit of Use]
GS1	10884838117850 [Primary]

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2025-05-29
• Device Publish Date: 2025-05-21

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838120563 - MR Patient Care Kit, Sample, Agents, 3160: 2025-05-29 KIT,SAMPLE,AGENTS,3160
• 00884838117839 - MR Patient Care Single Patch ECG Electrodes (25): 2025-05-29 QUADTRODE MRI ECG PAD,25/BOX
• 00884838117846 - MR Patient Care Multiple Patch ECG Electrodes (25): 2025-05-29 ELECTRODE, MRI ECG, QUADTRODE CV, 25/BOX
• 00884838117853 - MR Patient Care Neonatal ECG Electrodes (25): 2025-05-29ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX
• 00884838117853 - MR Patient Care Neonatal ECG Electrodes (25): 2025-05-29 ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX
• 00884838120532 - MR Patient Care Short Wide ECG 2.0 Cable AAMI: 2025-05-28 CAB,4 LD,CV MRI ECG,3160
• 00884838120549 - MR Patient Care Short Standard ECG 2.0 Cable AAMI: 2025-05-28 CAB,4 LD,MRI ECG,3160
• 00884838120693 - MR Patient Care Long Wide ECG 2.0 Cable AAMI: 2025-05-28 ECG Leadwire Set designed for use with the Expression MRI Patient Monitor when utlizing the system's Advanced ECG Gradient Filte
• 00884838120730 - MR Patient Care Long Extra Wide ECG 2.0 Cable AAMI: 2025-05-28 Advanced Apps ECG Cable for wireless ECG modules