Fresenius Kabi AmiCORE Apheresis System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

Class:

Class C medical device

Manufactured by:

Fresenius Kabi AG

Therapeutic area:

Hematology

Therapeutic indications:

The AmiCORE Apheresis System is an automated blood cell separator intended for use in the collection of blood components. The AmiCORE Apheresis System is indicated to collect: 1. Platelets Pheresis, Leukocytes Reduced (single or double units). 2. Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (single or double units) -- (P6R8884 kit code only) 3. Plasma (P6R8884 kit code only)

Product summary:

Device System Info:[Sterile Medical Device], Radiation sterilization by gamma or e-beam.; Models: AmiCORE Apheresis System - 6R8800, AmiCORE Apheresis Kit - Single Needle - P6R8880, AmiCORE Apheresis Kit - Single Needle with Two Platelet Containers - P6R8882, AmiCORE Apheresis Kit – Single Needle with Two Platelet Containers and PAS Connector - P6R8884, AmiCORE Apheresis Kit – Single Needle with Two Platelet Containers, PAS Connector, and Platelet Sampling System - P6R8888

Authorization date:

2020-02-07