Novo Vivo
Novo Vivo Suction Catheter
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Genesis Industries, Inc., United States |
|---|---|
| FDA product code | GBS |
| Device type | Catheter, Ventricular, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Axiom® Atraum™ With ClotStop® | Axiom Medical, Inc. | 69 |
| Axiom® PVC | Axiom Medical, Inc. | 24 |
| Silicone Thoracic Drain, S Type | Fortune Medical Instrument Corp. | 17 |
| Thoracic Drain | LivaNova USA, Inc. | 16 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 15 |
| Axiom® CWV Atraum™ With ClotStop® | Axiom Medical, Inc. | 14 |
| Argyle | Cardinal Health | 12 |
| Axiom® Dual-Sump Atraum™ With ClotStop® | Axiom Medical, Inc. | 9 |
| Axiom® Uni-Sump Atraum™ With ClotStop® | Axiom Medical, Inc. | 7 |
| Silicone Thoracic Drain, SF Type | Fortune Medical Instrument Corp. | 7 |
| Silicone Thoracic Drain, RF Type | Fortune Medical Instrument Corp. | 7 |
| Front1 Health Partners | Degania Silicone, Ltd. | 5 |
Showing 12 of 22. All products under Catheter, Ventricular, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K880376 | 1988-02-16 |
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.