Vietnam MOH registration 2400791ĐKLH/BYT-HTTB

Plasma Separator Module for the Closed-Loop Blood Transfusion System

VN: Bộ tách biệt huyết tương dùng cho hệ thống truyền máu hoàn hồi

Vietnam·Risk Class TTBYT Loại C·PSQ Set·Fenwal International, Inc.·Registered Jun 20, 2024

Registration details

Analysis ID: 2400791ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230619-0012
Product Type: PSQ Set
Product Code: 9305141

Company information

Manufacturer: Fenwal International, Inc.
Manufacturer Country: DOMINICAN REPUBLIC
Product Owner: Fresenius Medical Care
Authorized Representative: CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM

Technical details

Intended Use: The device is designed to be used with the CATSmart or C.A.T.S. blood recovery system. The C.A.T.S. and CATSmart devices, along with the accompanying disposable accessories, are blood recovery systems used to process the blood collected during or after surgery to obtain concentrated red blood cells that have been washed and are ready for transfusion. Additionally, the device is used to prepare the blood before surgery to obtain concentrated red blood cells, plasma, and platelet-rich plasma. The PSQ Set is a sterile device that is sterilized by Ethylene Oxide (EO) and is intended for single use only. PSQ is a program that performs the separation of plasma (PSQ). The patient's blood is collected in a standard blood bag containing anticoagulant. The disposable PSQ device supports the production of concentrated platelets from platelet-rich plasma (PRP).

Dates and status

Registration Date: Jun 20, 2024

About this record

Access comprehensive regulatory information for Plasma Separator Module for the Closed-Loop Blood Transfusion System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400791ĐKLH/BYT-HTTB and manufactured by Fenwal International, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN FRESENIUS KABI VIỆT NAM.

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