ARTG 398792ClearAir2 Plume Evacuation Unit - Evacuator, smoke, surgical
ARTG ID: 398792 · E & L May Pty Ltd · Prima Medical Ltd · Class I · Started November 02, 2022
Good Name: E & L May Pty Ltd - ClearAir2 Plume Evacuation Unit - Evacuator, smoke, surgical
- Risk Class
- Class I
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 398792
- Start Date
- November 02, 2022
- Effective Date
- November 02, 2022
- Country
- United Kingdom
- Address
- Suite E South 1st Floor The Wheelhouse Bond's Mill Estate, Stonehouse, GL10 3RF
A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and can also be used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view.
Access comprehensive regulatory information for ClearAir2 Plume Evacuation Unit - Evacuator, smoke, surgical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 398792 and sponsored by E & L May Pty Ltd, manufactured by Prima Medical Ltd in United Kingdom. The device registration started on November 02, 2022.
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