Diversatek Healthcare
Right Angle Thoracic Catheter, 24 French x 20 IN
7manufacturers in China registered for this device type
15catalogue numbers in this listing
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 | Diversatek Healthcare Inc, United States |
|---|---|
| FDA product code | GBS |
| Device type | Catheter, Ventricular, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-23 |
| Record revised | 2024-01-03 (version 7) |
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 |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 12 to 40 Fr; length 20 in |
| Distribution end date | 2023-06-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1240-16 | Catheter Gauge 16 Fr | In distribution |
| 1245-24 | Length 20 in | In distribution |
| 1245-36 | Catheter Gauge 36 Fr | In distribution |
| 1240-32 | Catheter Gauge 32 Fr | In distribution |
| 1245-20 | Catheter Gauge 20 Fr | In distribution |
| 1245-16 | Length 20 in | In distribution |
| 1240-40 | Catheter Gauge 40 Fr | In distribution |
| 1240-36 | Length 20 in | In distribution |
| 1245-32 | Length 20 in | In distribution |
| 1240-28 | Length 20 in | In distribution |
| 1240-20 | Length 20 in | In distribution |
| 1245-28 | Catheter Gauge 28 Fr | In distribution |
| 1245-40 | Length 20 in | In distribution |
| 1240-24 | Catheter Gauge 24 Fr | In distribution |
| 1240-12 | Length 20 in | Withdrawn |
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 |
| 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 |
| Axiom® CWV Facial Atraum™ With ClotStop® | Axiom Medical, Inc. | 4 |
Showing 12 of 22. All products under Catheter, Ventricular, General & Plastic Surgery
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.