Balloon Inflators
Catalogue number VDK-IF-12, listed by Jiangsu Vedkang Medical Science and Technology Co., Ltd., China, under Syringe, Balloon Inflation, Exempt. 16 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (7), Guangdong (4), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Brun Medical Co., Ltd. | Zhuzhou | Hunan | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Syringe, Balloon Inflation, Exempt
Record
| Listed by | Jiangsu Vedkang Medical Science and Technology Co., Ltd., China |
|---|---|
| FDA product code | PTM |
| Device type | Syringe, Balloon Inflation, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-20 |
| Record revised | 2024-08-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box, carton of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VDK-IF-12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| basixCOMPAK™ | Merit Medical Systems, Inc. | 58 |
| basixTOUCH™ | Merit Medical Systems, Inc. | 21 |
| Angioway | Lepu Medical Technology (Beijing) Co., Ltd. | 14 |
| Balloon inflation device | Tianck Medical Co., Ltd. | 9 |
| basixALPHA™ | Merit Medical Systems, Inc. | 8 |
| Genoss Inflator B30 | Genoss Co., Ltd. | 5 |
| basixTau™ | Merit Medical Systems, Inc. | 5 |
| Genoss Inflator B40 | Genoss Co., Ltd. | 5 |
| Namic | Medline Industries, Inc. | 4 |
| GM-30 Accessory Kit | Nipro Vascular Innovations Americas, Inc. | 4 |
| BlueFIRE™ | Merit Medical Systems, Inc. | 4 |
| basixSKY™ | Merit Medical Systems, Inc. | 4 |
Showing 12 of 25. All products under Syringe, Balloon Inflation, Exempt
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.