Smart Bulb

Primary DI

06009900408330

Basic UDI-DI Code

60099004083URO0373F

Reference

URO 037

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Wismed CC

Smart Bulb is a single use, sterile irrigation system, designed for controlled irrigation through an endoscope or accessory during urological and/or endoscopic procedures. It helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. The system is capable of producing dual flow i.e. background low intensity flow that is regulated by hydrostatic pressure by adjusting the height of the irrigation fluid reservoir and accelerated flow that depends on the force applied to the device by the hand of the operator. Lowering of the fluid reservoir below the patients’ level will cause background flow to cease. Inadvertent effects, such as stone migration caused by pressurized irrigation can complicate Ureterorenoscopy but are easily avoided with the use of the Smart Bulb. As a low volume system, it is less likely to subject the kidney to excessive intrapelvic pressures. Smart Bulb is operated by hand and due to its small size, it fits comfortably into the hand of the operator. The simple connection of the unit to the fluid supply provides the urologist with a very sensitive system capable of producing a broad range of flows, thus making both rigid and flexible ureteroscopy and stone treatment much easier.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).