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) CABLE, ELECTRODE (IKD) (1) DISPLAY, CATHODE-RAY TUBE, MEDICAL (DXJ) (1) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (1) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1) Monitor, oxygen, cutaneous, for infant not under gas anesthesia (KLK) (1) MONITOR, BED PATIENT (KMI) (1)

Premarket Exempt

No Yes

Clear

NA - 00884838074668 Catalog Number : 989803100811

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : KLK

Prescription Use : No

Device Count : 1

NA - 00884838075290 Catalog Number : 989803106091

Device Description : EEG Trunk Cable 2.7 meter

Device Class : 2

Duns Number: 314101143

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

IntelliVue Patient Monitor XG50 - 00884838076532 Catalog Number : 866063

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Philips IntelliVue ContactLess Biosensing - 00884838076723 Catalog Number : 867111

Device Class : 1

Duns Number: 314101143

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

PHILIPS IntelliVue GuardianSoftware - 00884838081925 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 IntelliVue X3 - 00884838082588 Catalog Number : 867030

Device Description : IntelliVue Multi-Measurement Module X3, compact, battery operated patient monito IntelliVue Multi-Measurement Module X3, compact, battery operated patient monitor and multi-measurement module.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

PHILIPS IntelliVue MX100 - 00884838082595 Catalog Number : 867033

Device Description : IntelliVue Patient Monitor MX100, compact, battery operated patient monitor.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

Philips IntelliVue Patient Monitoring - 00884838083332 Catalog Number : 866471

Device Description : The IntelliVue MX750 Patient Monitor has an optically-bonded 19 inch (469 mm) LC The IntelliVue MX750 Patient Monitor has an optically-bonded 19 inch (469 mm) LCD (TFT) widescreen display with projected capacitive touch technology. It is compatible with various measurement modules and measurement servers. The monitor provides as standard a 100BaseT LAN port, an RS232 port, four USB ports, a basic nurse call relay, and an analog ECG sync output. MX750 also provides one MSL connector for connecting up to two FMX-4 module racks (in the case of two racks, the racks are connected to each other in series and then plugged in to the MSL connector). Built-in to the front of the display is a Contactless ID and Communication module using RFID technology. Please refer to technical data sheet for more information.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

IntelliVue Hemodynamic Extension - 00884838083547 Catalog Number : 867039

Device Description : IntelliVue Hemodynamic Extension works together with the IntelliVue Multi-Measur IntelliVue Hemodynamic 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). Right Heart Cardiac Output (C.O.), continuous C.O. PiCCO, dual Invasive Pressure and continuous Temperature measurement can be selected via B-options.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : MHX

Prescription Use : Yes

Device Count : 1

IntelliVue Capnography Extension - 00884838083578 Catalog Number : 867040

Device Description : IntelliVue Capnography Extension works together with the IntelliVue Multi-Measur IntelliVue Capnography 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 varies care areas inside the hospital. Optional Right Heart Cardiac Output (C.O.), continuous C.O. PiCCO, dual Invasive Pressure and continuous Temperature measurement can be selected via B-options.

Device Class : 2

Duns Number: 314101143

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

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