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

TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY (DRG) (2) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (2) MONITOR, CARBON-DIOXIDE, CUTANEOUS (LKD) (1) MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) (DRT) (1) AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL (DRQ) (1) Monitor, breathing frequency (BZQ) (1) Oximeter (DQA) (1) DETECTOR AND ALARM, ARRHYTHMIA (DSI) (1)

Premarket Exempt

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IntelliVue CL SpO2 Pod - 00884838020665 Catalog Number : 865215

Device Description : IntelliVue Cableless SpO2 Pod, a battery-powered pulse oximeter device for Cable IntelliVue Cableless SpO2 Pod, a battery-powered pulse oximeter device for Cableless Monitoring of patients. The IntelliVue CL SpO2 Pod provides arterial oxygen saturation, pulse rate and pleth wave form via short range radio to the receiving system.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

IntelliVue CL NBP Pod - 00884838020672 Catalog Number : 865216

Device Description : IntelliVue Cableless NBP Pod, a battery-powered non-invasive blood pressure devi IntelliVue Cableless NBP Pod, a battery-powered non-invasive blood pressure device for Cableless Monitoring of patients. The IntelliVue CL NBP Pod provides non-invasive blood pressure and pulse rate via short range radio to the receiving system.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

IntelliVue CL Respiration Pod - 00884838020689 Catalog Number : 865218

Device Description : IntelliVue Cableless Respiration Pod, a battery-powered respiration device for f IntelliVue Cableless Respiration Pod, a battery-powered respiration device for frequent Cableless Monitoring of patients. The IntelliVue CL Respiration Pod provides the respiration rate and optional the pulse rate via short range radio to the receiving system.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue MX800 patient monitor - 00884838020733 Catalog Number : 865240

Device Description : The IntelliVue MX800 patient monitor is operated primarily via touch screen. It The IntelliVue MX800 patient monitor is operated primarily via touch screen. It has an integrated 19" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A)/ all Multi-Measurement Module Extensions/IntelliVue MMX (867036)/ IntelliVue X3 (867030)/ the Flexible Module Server (M8048A) and the individual IntelliVue measurement modules.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue Remote Control - 00884838020740 Catalog Number : 865244

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

PHILIPS IntelliVue TcG10 - 00884838020764 Catalog Number : 865298

Device Description : IntelliVue TcG10 Gas Modul for external transcutaneous O2 and CO2 measurement

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : LKD

Prescription Use : Yes

Device Count : 1

Philips SO2 Optical Module - 00884838020849 Catalog Number : 989803151591

Device Description : SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular catheters such as scvO2 and svO2. See Instructions for Use for compatible catheters, catheters are not available from Philips.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

PHILIPS IntelliVue Invasive Pressure Module - 00884838020917 Catalog Number : 862277

Device Description : Invasive Blood Pressure Module

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DRQ

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue Intravascular Oxygen Saturation Module - 00884838020931 Catalog Number : 865124

Device Description : Intravascular Oxygen Saturation Module for use with IntelliVue Patient Monitors. Intravascular Oxygen Saturation Module for use with IntelliVue Patient Monitors. The Module allows continuous measurement of mixed venous oxygen saturation (SvO2) and central venous oxygen saturation (ScvO2).

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue Cardiac Output Parameter Module - 00884838020948 Catalog Number : 862279

Device Description : Cardiac Output Parameter Module for use with IntelliVue Patient Monitors. The Ca Cardiac Output Parameter Module for use with IntelliVue Patient Monitors. The Cardiac Output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using a technique called thermodilution. Supports either preloaded syringes or flow-through (CO-Set) technique.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : DRT

Prescription Use : Yes

Device Count : 1

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