Marina Medical
Surgifresh Turbo Smoke Evacuator Complete Package, 110v, Footswitch, Wheel, Handle Kit, ULPA Smoke Filter, 5 Prefilters, 5 tubing
4manufacturers in China registered for this device type
19catalogue 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 | Marina Medical Instruments, Inc., United States |
|---|---|
| FDA product code | FCZ |
| Device type | Tube, Smoke Removal, Endoscopic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-18 |
| Record revised | 2025-01-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Catheter gauge 5 to 30 Fr; length 35 to 41 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 190-641 | Catheter Gauge 11 Fr | In distribution |
| 190-622 | Length 41 cm | In distribution |
| 190-644 | Catheter Gauge 14 Fr | In distribution |
| 190-610 | In distribution | |
| 300-350 | In distribution | |
| 190-644XL | Catheter Gauge 14 Fr | In distribution |
| 190-642XL | Catheter Gauge 12 Fr | In distribution |
| 190-620 | Length 35 cm | In distribution |
| 190-624C | Length 37 cm | In distribution |
| 300-356 | In distribution | |
| 190-612 | Catheter Gauge 30 Fr | In distribution |
| 190-609 | In distribution | |
| 190-635 | Catheter Gauge 5 Fr | In distribution |
| 300-351 | In distribution | |
| 300-312 | In distribution | |
| 190-637LC | In distribution | |
| 190-638LC | Catheter Gauge 8 Fr | In distribution |
| 190-642C | Catheter Gauge 12 Fr | In distribution |
| 300-355 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgimedics® | Coastal Life Technologies, Inc. | 40 |
| Gynex | Gynex Corporation | 6 |
| Tube, Smoke Removal, Endoscopic | Coastal Life Technologies, Inc. | 5 |
| Pneuview XE | Lexion Medical, LLC. | 2 |
| 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.