Dialysis Pressure Band

Primary DI

08683948036830

Basic UDI-DI Code

B-08683948036830

Reference

21038

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Ağaoğlu Tıbbi Sağlık Tekstil San. ve Tic. A.Ş.

Used for covering the hole created by the needle after hemodialysis and taking blood. The special pad absorbs the blood in the applied area and retains the blood thanks to superabsorbent polymers in its formation. During this absorption process the pad thickens and applies a pressure on the needle hole which helps hemeostatis. Provides a secure environment by protecting the large needle hole against the penetration of microorganisms and fluids. . The products do not include any accessories. There are 2 types of sizes on dialysis pressure band. (38cmx38cm, 38cmx72cm) According to 93/42/EEC directive Annex-IX Rule IV Classification Rule; they are all non-invasive devices that come into contact with injured skin and fall into Class I as they are used as a mechanical barrier for absorption or suppression of secretions. Classification on the basis of time; short-term - medical devices intended for continuous use of less than 30 days.

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