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 ID00884838107809
NIH Device Record Keyc3c2c771-4d4c-4709-99f5-bfcbcaebb8aa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Monitor 6500
Version Model NumberPatient Monitor
Catalog Number867315
Company DUNS314101143
Company NamePhilips Medizin Systeme Böblingen GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 57 KiloPascal and 107.5 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838107809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-19
Device Publish Date2025-11-11

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

00884838107809 - Patient Monitor 65002025-11-19The 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.
00884838107809 - Patient Monitor 65002025-11-19 The Patient Monitors 6100, 6300 and 6500 (aka Evoline Patient Monitors) are compact, portable and stationary units with TFT LCD
00884838117440 - NOUN2025-08-29 36" patient cable (standard), for use only with the DigiTrak XT recorder
00884838120303 - MR Patient Care Universal Gating Interface2025-08-01 Gating cable for use between any Expression MR patient monitor and any wired or wireless MRI system accessories.
00884838126411 - Leads2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs, 10-lead, AAMI color-coding, 3mm needle
00884838126428 - Leads2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs,10-lead, IEC color-coding, 4mm banana
00884838114937 - NIBP Cuffs2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
00884838114951 - NIBP Cuffs2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
00884838114975 - NIBP Cuffs2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
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