TEMED Gas Diffuser A device designed for controlled diffusion of a medical gas [e.g., carbon dioxide (CO2), humidified air] into an open surgical wound during an open surgical gas…
TEMED Gas Diffuser A device designed for controlled diffusion of a medical gas [e.g., carbon dioxide (CO2), humidified air] into an open surgical wound during an open surgical gas insufflation procedure, typically to minimize the risk of air embolism or reduce heat transfer from the surgical wound. The diffuser typically includes connection tubing and may also include a filter. This is a single-use device.
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Temed | Listed by | Temed, United Kingdom |
| FDA product code | HIF |
| Device type | Insufflator, Laparoscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1730 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K173545 |
| Record published | 2023-04-21 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.