Patient Monitor 6500 867315

GUDID 00884838107809

The Patient Monitors 6100, 6300 and 6500 (aka Evoline Patient Monitors) are compact, portable and stationary units with TFT LCD flat panel display (10 inch and 15 inch and built-in CPU. The Monitors are outfitted with a touchscreen interface with multi-finger touch screen capability as their primary input. The patient monitors have integrated physiological measurements such as ECG/Resp, SPO2, NIBP, IBP and Temperature. In addition to their integrated physiological measurements, the Patient Monitors can extend their measurement capabilities by connecting to external measurements via their dedicated [1]Measurement Rack 6000 (867317) and their integrated FlexLink connector. The Patient Monitors run on mains power or on internal battery. The Patient Monitors operate in hospital transport environments and can communicate with the Central Station via LAN or wireless link.

Philips Medizin Systeme Böblingen GmbH

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 00884838107809
• NIH Device Record Key: c3c2c771-4d4c-4709-99f5-bfcbcaebb8aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor 6500
• Version Model Number: Patient Monitor
• Catalog Number: 867315
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 107.5 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838107809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250453

FDA Product Code

• MHX: Monitor, Physiological, Patient(With 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: 2025-11-19
• Device Publish Date: 2025-11-11

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838117433 - NOUN: 2026-03-27 24" patient cable, for use only with the DigiTrak XT recorder,
• 00884838113770 - MR Patient Care Adult SpO2 Clip: 2026-03-24 Reusable SpO2 finger clip designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Adult patients
• 00884838100978 - MR Patient Care Pediatric SpO2 Clip: 2026-03-24 Reusable SpO2 finger clip designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Pediatric patients
• 00884838128880 - Patient Information Center iX: 2026-03-17 Patient Information Center iX
• 00884838129214 - Care Assist: 2026-03-17 Care Assist
• 00884838129221 - Care Assist: 2026-03-17 Care Assist
• 00884838117877 - MR Patient Care Pediatric SpO2 Clip: 2026-03-17 Reusable SpO2 finger clip designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Pediatric patients
• 00884838117358 - patient lead wire: 2026-03-13 Std 10-lead Patient Cable IEC