No Bubble TURP

Primary DI

06009900408347

Basic UDI-DI Code

60099004083URO00532

Reference

URO 005

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Wismed CC

The No Bubble TURP set is a sterile, single use irrigation device for conducting fluids from its source (bag or bottle) into the patients lower urinary system. It is an externally communicating device and requires an interphase typicaly in the form of a cystoscope to which it connects. It is intended to provide irrigation during urological endoscopic procedures like cystoscopy or Transurethral Resection of Prostate and other surgical procedures. It can be also used to provide short term continuous irrigation of the bladder when indicated. The device has been developed based on detailed feedback from practicing urologists and urological scrub nurses. There was an apparent need for a device that would be of high quality and would satisfy unfulfilled needs of end-users. The No Bubble TURP set is equipped with soft drip chambers with water dispersers to reduce the number of bubbles that enter the set during rapid irrigation. The streams of water from the disperser are directed onto the inner surface of the chambers to lower their kintic energy and to continuously wash the chamber wall of fog that tends to accumulate when using warm irigation fluids, thus affording fluid flow monitoring. The colour coded pinch clamps are placed in the sterile field during operation to allow the scrub nurse or surgeon to conveniently change from one irrigation bag to another without interrupting the procedure. The entire set is made of DEHP-free material to make it safer for the patients and to reduce the impact of disposals on the environment.

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