Medtronic Affinity Fusion Oxygenation System

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Tersedia dari:

MEDTRONIC INTERNATIONAL, LTD.

Kelas:

Class C medical device

Diproduksi oleh:

Medtronic Inc.

Area terapi:

Cardiovascular

Indikasi Terapi:

Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine CPB procedures up to 6 hours in duration. It is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery. It is suitable for transfer of the volatile anesthetics isoflurane and sevoflurane by administration through the oxygenator gas inlet by means of a suitable gas vaporizer. CVR with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during VAVD procedures and after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

Ringkasan produk:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], EO sterilization; Models: Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with balance Biosurface - BB841, Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface - BB811, Affinity Orbit Holder System - AUH2093, Temperature Probe - ATP210, Affinity Manifold Holder - AMH2014, Recirculation Line - RCL841, Affinity Orbit Arterial Filter Arm - AUH4014

Tanggal Otorisasi:

2014-08-21