Intussusception Air Reduction Kit, No Tip
Catalogue number IARK-1, listed by GRI Medical Products, Inc., United States, under Evacuator, Gastro-Urology. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
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 | GRI Medical Products, Inc., United States |
|---|---|
| FDA product code | KQT |
| Device type | Evacuator, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4370 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-12-18 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IARK-1 | 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
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.