Pneuview XE
Laparoscopic Smoke Elimination Device
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Unimicro Medical Systems (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Heng Chuang Plastic & Metal Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Lexion Medical, LLC., United States |
|---|---|
| FDA product code | FCZ |
| Device type | Tube, Smoke Removal, Endoscopic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-02-15 |
| Record revised | 2020-11-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2020-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9660-XE | In distribution | |
| 9660-XENS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgimedics® | Coastal Life Technologies, Inc. | 40 |
| Marina Medical | Marina Medical Instruments, Inc. | 19 |
| Gynex | Gynex Corporation | 6 |
| Tube, Smoke Removal, Endoscopic | Coastal Life Technologies, Inc. | 5 |
| Tube, Smoke Removal, Endoscopic | Karl Storz GmbH & Co. KG | 2 |
| SeeClear MAX Laparoscopic Smoke Evacuation System | Coopersurgical, Inc. | 1 |
| Laparoscopic Smoke Evacuator | THE O R Company PTY Ltd | 1 |
| Laparoscopic Tubing | Megadyne Medical Products, Inc. | 1 |
| Speculum Tubing | Megadyne Medical Products, Inc. | 1 |
| Unimax | Unimax Medical Systems Inc. | 1 |
| Sesis | Surgease Innovations Ltd | 1 |
| Tubing, sterile, for UHl smoke evacuation | Promepla | 1 |
Showing 12 of 17. All products under Tube, Smoke Removal, Endoscopic
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.