CollectEVAC
Sterile device with tubing and adapter for use with ACMI and STORZ/Wolf resectoscopes
5manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ucomfor Medical Co., Ltd. | Shanghai | Shanghai | Exporter | 17 |
| Shenzhen Trious Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Civco Medical Instruments Co., Inc., United States |
|---|---|
| FDA product code | KQT |
| Device type | Evacuator, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4370 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-03 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 52 to 85 °F; Special storage condition: Keep Away from Sunlight |
| Sizes | Height 17.8 cm; length 18.3 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 610-954 | Height 17.8 cm | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Evacuator, Gastro-Urology | Stryker GmbH | 34 |
| BioVac | Us Endoscopy | 7 |
| Evacuator, Gastro-Urology | Richard Wolf Gmbh | 3 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 3 |
| Toomey | Gyrus Acmi, Inc. | 2 |
| Cook CollectEVAC | Civco Medical Instruments Co., Inc. | 2 |
| Trious | Shenzhen Trious Medical Technology Co., Ltd. | 2 |
| AED | National Advanced Endoscopy Devices, Inc. | 2 |
| Occlusion Disc | GRI Medical Products, Inc. | 1 |
| Intussusception Air Reduction Kit with Pink Tip | GRI Medical Products, Inc. | 1 |
| USA Elite | Gyrus Acmi, Inc. | 1 |
| Intussusception Air Reduction Bulb & Gauge | GRI Medical Products, Inc. | 1 |
Showing 12 of 29. All products under Evacuator, Gastro-Urology
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-08-01 | Class II | Packaging | A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product. | 52 kits | 2015-01-28 |
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.