Eu Mdr Eu Md Class 2b On The Market

Administration System for Theranostics

ASTER SYSTEM (Administration System for Theranostics) is a system used for the infusion of radiopharmaceuticals in radiometabolic therapy.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
08056351100151
Basic UDI-DI Code
8056351100000ASTERSYSY9
Reference
135000074
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

The ASTER System consists of the following medical devices: 1. Aster Stand (Stand and Lead Glass Pot) 2. BBraun infusion pump The system allows to automatically manage, from a disposable vial inside the Lead Glass Pot, the infusion of the radiopharmaceutical used during Radiometabolic Therapy, thus minimising the operator's exposure to radioactivity and the risk of radioactive contamination of the environment. The ASTER SYSTEM was designed for the following purposes: 1) Safely store the radiopharmaceutical and protect the operator from radiation by means of the ASTER STAND medical device. 2) Automatically administer the radiopharmaceutical to the patient via the BBraun infusion pump and the two ASTER STDS (Safety Transfer Disposable Set) consumables as well as the pump manufacturer’s infusion set.

Medical Purpose

ASTER SYSTEM (Administration System for Theranostics) is a system used for the infusion of radiopharmaceuticals in radiometabolic therapy.

CND Nomenclature Codes

Code Description
Z12030301 INFUSION PUMPS
Z12030380 INFUSION INSTRUMENTS - HARDWARE ACCESSORIES

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