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Anesthesia Machine - India CDSCO Medical Device Registration

Anesthesia Machine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001167_09278f2c658d5abc1be919a3e6b64c44_3cbfd6913d2d83a6ecfcf64d122264ee. This device is marketed under the brand name PSVProโ„ข. 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
Anesthesia Machine
UID: IMP/MD/2023/001167_09278f2c658d5abc1be919a3e6b64c44_3cbfd6913d2d83a6ecfcf64d122264ee

Brand Name

PSVProโ„ข

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Aisys Carestation is scalable, flexible, and functionally integrated, featuring the most advanced design, ventilation, respiratory monitoring, and breathing system. In addition, module bays allow for the physical integration of legacy Datex-Ohmeda patient monitors and supports mounting of other GE Healthcare monitors. Optionally, the open architecture design supports mounting of non-Datex-Ohmeda patient monitors, record keeping, and connections to the hospital information system. The INview movable display arm helps keep the anesthetistโ€™s focus on the patient by offering control of all hemodynamic, gas delivery, anesthetic agent, and ventilation parameters. This anesthesia system is designed for mixing and delivering inhalation anesthetics, Air, O2, and N2O. The anesthesia systemโ€™s small breathing system volume allows an anesthetic agent delivery response time of less than 7 seconds. (PSVProโ„ข) This anesthesia system uses SmartVent ventilation technology offering Volume Control Ventilation with tidal volume compensation and electronic PEEP. The proven SmartVent technology also features optional Pressure Control Ventilation, Pressure Support Ventilation with an Apnea Backup (PSVProโ„ข) that is used for spontaneously breathing patients, Synchronized Intermittent Mandatory Ventilation (PSVProโ„ข) modes, Pressure Control Ventilation- Volume Guarantee (PSVProโ„ข), Constant Positive Airway Pressure/ Pressure Support Ventilation (PSVProโ„ข), and VCV cardiac bypass. In Volume Control Ventilation, a patient can be ventilated using a minimal tidal volume of 20 ml. In Pressure Control Ventilation, volumes as low as 5 ml can be measured. These advanced features allow for the ventilation of neonates to adult patients.

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