Vietnam MOH registration 2403309ĐKLH/BYT-HTTB

Artificial Lung and Anticoagulant-Coated Wires

VN: Bộ phổi nhân tạo và dây dẫn phủ chất chống đông máu

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Nov 06, 2024

Registration details

Analysis ID: 2403309ĐKLH/BYT-HTTB
Submission ID: 17000132/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIỆT GIA

Technical details

Intended Use: The PLS / PLS Plus system, which uses a combination of oxygen-permeable membrane and centrifugal pump, is designed for both extracorporeal lung support and cardiac support, or for simultaneous cardiac and lung support. The PLS lung system can operate to support circulation with blood flow rates from 0.5 to 7 liters/minute. The oxygenation performance is designed to treat adult patients within the blood flow range. If used for smaller patients, the blood flow rate required is higher. It can support both arterial and venous circulation. Venous circulation only supports lung function and does not provide the heart's pumping function. However, venous circulation can support or take over the heart's pumping function and can simultaneously receive or support the gas exchange of the lungs as required. At the designated flow rate, the oxygen-permeable membrane diffuses oxygen into the blood and removes carbon dioxide. Furthermore, the blood can be cooled or warmed, as required, by the integrated heat exchanger in the artificial lung. This means that the PLS/ PLS Plus system can be used within the designated temperature range to rewarm the patient's body (e.g., after a case of accidental hypothermia) or to cool the body (e.g., after successful cardiopulmonary resuscitation). Partial blood flow to a limb or organ is also feasible, depending on the vascular access. The support system is generally applicable to all types of applications such as: Supporting circulation until recovery or as a temporary bridge to recovery and weaning from the support system ("recovery bridge"). Bridge to transplantation ("transplant bridge"). Bridge to another treatment modality or further decision ("treatment bridge" or "decision bridge"). Supporting circulation to

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Artificial Lung and Anticoagulant-Coated Wires in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403309ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIỆT GIA.

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