Argyle
Silicone Thoracic Catheter with Connector Right Angle
7manufacturers in China registered for this device type
12catalogue 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 | Cardinal Health, 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, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-29 |
| Record revised | 2024-11-05 (version 4) |
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 |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 20 to 40 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8888573063 | Catheter Gauge 36 Fr | In distribution |
| 8888572545 | Catheter Gauge 24 Fr | In distribution |
| 8888573055 | Catheter Gauge 32 Fr | In distribution |
| 8888573022 | Catheter Gauge 32 Fr | In distribution |
| 8888572578 | Catheter Gauge 36 Fr | In distribution |
| 8888572586 | Catheter Gauge 40 Fr | In distribution |
| 8888572560 | Catheter Gauge 32 Fr | In distribution |
| 8888573550 | Catheter Gauge 28 Fr | In distribution |
| 8888572537 | Catheter Gauge 20 Fr | In distribution |
| 8888573048 | Catheter Gauge 28 Fr | In distribution |
| 8888573568 | Catheter Gauge 34 Fr | In distribution |
| 8888572552 | Catheter Gauge 28 Fr | 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 |
| 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.