Blood transfusion set

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

REM Systems Pty Ltd

Class:

Class IIa

Manufactured by:

Caesarea Medical Electronics Limited 16 Shacham Street Industrial Park Caesarea North, P.O. Box 3009, Caesarea, 3088900 Israel

Therapeutic area:

38569 - Blood transfusion set

Therapeutic indications:

The Infusion sets family are part of the BodyGuard? infusion pump system which is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, intrathecal, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents, blood or blood products infusion and general fluids therapy in hospital and home care environments. The Infusion sets are sold as sterile devices intended for single use only. The user must also consult the infusion pump Intended Use prior to using the system. Blood administration sets are intended to be used with blood and blood products administered intravenously in a hospital or clinical environment.

Authorization status:

A

Authorization date:

2021-02-24