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Multiparameter Monitor with Critical Parameters - India CDSCO Medical Device Registration

Multiparameter Monitor with Critical Parameters is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000806_d2c256fe447e0d61f711f3f1b6d2b0d2_ee6afea3b1c1ecbfbfee3af9e18d76fb. This device is marketed under the brand name Carescape Central Station. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Multiparameter Monitor with Critical Parameters
UID: IMP/MD/2022/000806_d2c256fe447e0d61f711f3f1b6d2b0d2_ee6afea3b1c1ecbfbfee3af9e18d76fb

Brand Name

Carescape Central Station

Device Class

Class C

Approving Authority

CDSCO

Product Information

The CARESCAPE Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems. Physiological parameters and waveforms include electrocardiograph (Carescape Central Station), pulse oximetry (Carescape Central Station), invasive blood pressures (Carescape Central Station), non-invasive blood pressure (Carescape Central Station), respiration (Carescape Central Station), ventilator (Carescape Central Station), carbon dioxide (Carescape Central Station), oxygen (Carescape Central Station), mass spectrometry (Carescape Central Station), temperature (Carescape Central Station) and bispectral index (Carescape Central Station). Beat to beat patient information for parameters and waveforms from the bedside and telemetry systems can be displayed. Patient monitor and telemetry system settings can be adjusted. Parameter values derived from patient data can be calculated, displayed, and printed. The CARESCAPE Central Station supports the ability to access information from GE products and hospital intranet in a web browser format. Additionally, CARESCAPE Central Station supports the ability to access patient information collected from the CARESCAPE network.

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