Philips Medizin Systeme Böblingen GmbH

Address:HEWLETT-PACKARD STRASSE 2,BOEBLINGEN Baden-Wurttemberg,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (4) Alarm, Blood-Pressure (DSJ) (1) Computer, Blood-Pressure (DSK) (1) Computer, Diagnostic, Pre-Programmed, Single-Function (DXG) (1) DISPLAY, CATHODE-RAY TUBE, MEDICAL (DXJ) (1) Detector And Alarm, Arrhythmia (DSI) (1) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1) Oximeter (DQA) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) System, Monitoring, Perinatal (HGM) (1) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (1) System, network and communication, physiological monitors (MSX) (1)

Premarket Exempt

No Yes

Clear

IntelliVue Microstream Extension - 00884838083585 Catalog Number : 867041

Device Description : Microstream CO2 Extension works together with the IntelliVue Multi-Measurement M Microstream CO2 Extension works together with the IntelliVue Multi-Measurement Module (M3001A/AL), IntelliVue X2 Multi-Measurement Module (M3002A), IntelliVue MP2 Patient Monitor (M8102A), IntelliVue X3 (867030) and IntelliVue MX100 (867033). The base product provides CO2 waveform, inspired minimum (imCO2), endtidal CO2 (etCO2) and Airway Respiration Rate (awRR) of intubated and non-intubated adult, pediatric and neonatal patients. Optional Right Heart Cardiac Output (C.O.), continuous C.O. PiCCO, dual Invasive Pressure and continuous Temperature measurement can be selected via B-options. With option E60 the Microstream CO2 extension can also be used for out-of-hospital transport.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue Dock - 00884838085244 Catalog Number : 867043

Device Description : IntelliVue Dock. Docking solution for X3 and MX100 monitors, providing mounting, IntelliVue Dock. Docking solution for X3 and MX100 monitors, providing mounting, AC power, LAN, and Flexible Sync Out. To be used with standalone IntelliVue X3 or IntelliVue MX100 monitors. Includes Universal Clamp and Cable Management Hook. Note that IntelliVue Dock cannot be used for connecting IntelliVue X3 to an IntelliVue host monitor.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue GuardianSoftware - 00884838085718 Catalog Number : 866009

Device Description : IntelliVue GuardianSoftware is a software-only product. It is the core of the Gu IntelliVue GuardianSoftware is a software-only product. It is the core of the Guardian General Care Solution, which provides fully customizable workflow support for automated vital signs taking, early warning scoring, patient deteroration detection, caregiver notification and care escalation for medical/surgical care, ED waiting/triage and other general care areas. It also mediates the data flow between the devices and hospital systems. Guardian Software license options listed enable desired features and capabilities for specified number of patients, clients, selected measurement technologies as well as required connectivity to hospital systems.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DXJ

Prescription Use : Yes

Device Count : 1

PHILIPS Masimo O3 Module - 00884838086654 Catalog Number : 867184

Device Description : Masimo O3 Plug-in Module for IntelliVue Patient Monitors to connect the Masimo O Masimo O3 Plug-in Module for IntelliVue Patient Monitors to connect the Masimo O3 Measurement Device (989803203021)

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DSI, DSJ, DSK, DXG, DXN, MHX

Prescription Use : Yes

Device Count : 1

PHILIPS Masimo CO2 Module - 00884838086661 Catalog Number : 867185

Device Description : Masimo CO2 Plug-in Module for IntelliVue Patient Monitors to connect ISA CO2 (98 Masimo CO2 Plug-in Module for IntelliVue Patient Monitors to connect ISA CO2 (989803203031) IRMA CO2 (989803203041) Measurement Device

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

IntelliVue Multi-Measurement Module MMX - 00884838086760 Catalog Number : 867036

Device Description : IntelliVue MMX, compact multi-measurement module. Designed for use with IntelliV IntelliVue MMX, compact multi-measurement module. Designed for use with IntelliVue patient monitors for stationary monitoring and monitoring during in-hospital patient transports.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Philips IntelliVue Patient Monitoring - 00884838086982 Catalog Number : 866468

Device Description : The IntelliVue FMX-4 Flexible Module Rack provides 4 module slots for use with i The IntelliVue FMX-4 Flexible Module Rack provides 4 module slots for use with individual measurement modules and the recorder. The optional E20 Multi Measurement Module mount provides a mounting plate with an SRL connector for attaching a multi-measurement module. The FMX-4 is only compatible with IntelliVue MX750 and MX850 patient monitors.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

EarlyVue VS30 - 00884838091412 Catalog Number : 863380

Device Description : EarlyVue VS30 Vitals monitor

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

IntelliVue XDS Software - 00884838092099 Catalog Number : 867019

Device Description : IntelliVue XDS Software

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MSX

Prescription Use : Yes

Device Count : 1

PHILIPS Avalon Toco+ MP Transducer - 00884838093188 Catalog Number : 867245

Device Description : The device is intended to be used for monitoring and recording of, and to genera The device is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates

Device Class : 1

Duns Number: 314101143

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

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