BioVac
The disposable BioVac direct suction device is indicated for transendoscopic evacuation, debulking, and/or lysing of blood, retained blood clots, or fluid, such as residual stool, within…
The disposable BioVac direct suction device is indicated for transendoscopic evacuation, debulking, and/or lysing of blood, retained blood clots, or fluid, such as residual stool, within the gastrointestinal tract through the biopsy/suction channel of flexible gastrointestinal endoscopes. It also provides access for endoscopic device passage and exchange, and allows for supplemental intraprocedural irrigation when desired.
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 | Us Endoscopy, United States |
|---|---|
| FDA product code | KQT |
| Device type | Evacuator, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4370 |
| Premarket notification | Exempt |
| Record published | 2020-04-01 |
| Record revised | 2020-03-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry |
| Packaging | Case of 5, box of 5 |
| Distribution end date | 2020-11-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00711513 | In distribution | |
| 00711511 | In distribution | |
| 00711512 | In distribution | |
| 00711513 | Withdrawn | |
| 00711511 | Withdrawn | |
| 00711512 | Withdrawn | |
| 00711511 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Evacuator, Gastro-Urology | Stryker GmbH | 34 |
| 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 |
| Ahto | Stryker GmbH | 1 |
Showing 12 of 29. All products under Evacuator, Gastro-Urology
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.