Nebulae SRS Tubing Set
The NEBULAE SRS Tubing Set filters recirculating carbon dioxide during laparoscopic surgery to remove smoke particles and improve visualization. It is the sterile, single-use fluid-path…
The NEBULAE SRS Tubing Set filters recirculating carbon dioxide during laparoscopic surgery to remove smoke particles and improve visualization. It is the sterile, single-use fluid-path component of the NEBULAE SRS system and connects to the patient through two trocar connections.
The set contains an integrated cartridge with a diaphragm pump, an ultra-low particulate air filter with activated carbon, fluid traps and PVC tubing. The separate reusable pump motor drives the diaphragm pump head in the cartridge, moving gas through the filter and back to the pneumoperitoneum.
Tubing and Supply
The set includes ten feet of DEHP-free PVC tubing and connectors for the trocars. Fluid traps collect moisture within the gas circuit. The disposable set is sterilized by gamma irradiation and is used with the dedicated NEBULAE SRS pump.
Who Else Makes It
Concentrated in Zhejiang (1), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Northgate Technologies Inc., United States |
|---|---|
| FDA product code | FYD |
| Device type | Apparatus, Exhaust, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K202944 |
| Record published | 2023-02-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7-510-57 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 57 |
| Surgimedics® | Coastal Life Technologies, Inc. | 23 |
| Virosafe | ConMed Corporation | 22 |
| Buffalo Filter | Buffalo Filter Co., Inc. | 22 |
| ACU-Evac | Acuderm, Inc. | 21 |
| Neptune | Stryker GmbH | 14 |
| RapidVac | Covidien LP | 12 |
| Megadyne | Megadyne Medical Products, Inc. | 12 |
| Geiger Smoke Evacuator Filter | Dermatologic LAB AND Supply, Inc. | 12 |
| Apparatus, Exhaust, Surgical | Stryker GmbH | 11 |
| Apparatus, Exhaust, Surgical | ConMed Corporation | 10 |
| Conmed Buffalo Filter | ConMed Corporation | 10 |
Showing 12 of 142. All products under Apparatus, Exhaust, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202944 | 2021-03-25 |
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.