Medtronic Affinity Fusion™ Oxygenation System with Cortiva™ Bioactive Surface

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Tersedia dari:

MEDTRONIC INTERNATIONAL, LTD.

Kelas:

Class D medical device

Diproduksi oleh:

Medtronic Inc.

Area terapi:

Cardiovascular

Indikasi Terapi:

The oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool/warm the blood during routine cardiopulmonary bypass procedures up to 6 hours. It is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during cardiopulmonary bypass 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. The cardiotomy/venous reservoir 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. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures, for use 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:[Sterile Medical Device], EO Sterilization; Models: Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface and Cardiotomy/Venous Reservoir with Balance™ Biosurface - CB841, Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface - CB811, Affinity™ temperature probe - ATP210, Affinity Orbit™ holder system - AUH2093, Affinity™ manifold holder - AMH2014, Recirculation line - RCL841

Tanggal Otorisasi:

2017-10-20