FX 3000MD type LCD21

Organization name

EMTEL Śliwa spółka komandytowa

SRN

PL-MF-000006848

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW017

  Use only and exclusively manufacturer-recommended patient and sensor cables
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Poland; available across 32 countries total.

Trade name

FX 3000MD type LCD21

UDI-DI code

59044737176788

Basic UDI-DI

B-59044737176788

Reference / catalog number

FX3000MDLCD21

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

FX 3000MD is a multi-functional bedside monitor which enables monitoring and supervision of vital signs of patients at ICUs, operating rooms and at pre- and post- operative wards. It is also designed to work in neonates units. FX 3000MD ensures monitoring and supervision the following parameters (optionally): - electrocardiogram (ECG), - respiration (reographic method), - arterial blood pressure NIBP (non-invasive method), - arterial, venous blood pressure and others IBPs, - pulse oximetry SpO2, - carbon dioxide concentration ETCO2 in patients’ in exhaled and inspired air, - cardiac output (together with hemodynamic calculations), - ST analysis (slope and level), - ECG arrhythmia analysis, - oxygen concentration in gas mixture, - anesthetic gas concentration (N2O, ISO, ENF, HAL, SEV, DES) - biseptrical index (BIS) - electroencephalography (EEG), - impedance cardiography module (ICG).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z1203020201MULTI–PARAMETER PATIENT BEDSIDE MONITORS