Tru-Close Suction Drainage System
Tru-Close Suction Drainage System - 500ml - "D" port small
58manufacturers in China registered for this device type
19catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (9). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Changshu Beyond Medical Device Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 9 |
| Fansheng Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 8 |
Showing 12 of 58. All 58 manufacturers in China registered for Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Record
| Listed by | Uresil, LLC, United States |
|---|---|
| FDA product code | GCY |
| Device type | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4680 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-09-11 |
| Record revised | 2021-12-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Dispenser of 5, shipper of 2, shipper of 10, shipper of 5 |
| Sizes | Total volume 300 to 1000 ml |
| Distribution end date | 2030-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCS500D | Total Volume 500 ml | In distribution |
| TCS300D | Total Volume 300 ml | In distribution |
| TCS500D | Total Volume 500 ml | In distribution |
| TCS300D | Total Volume 300 ml | In distribution |
| TCS1000 | Total Volume 1000 ml | In distribution |
| TCS500 | Total Volume 500 ml | In distribution |
| TCS500 | Total Volume 500 ml | In distribution |
| TCS300D | Total Volume 300 ml | In distribution |
| TCS500DS | Total Volume 500 ml | In distribution |
| TCS500 | Total Volume 500 ml | In distribution |
| TCS300D | Total Volume 300 ml | In distribution |
| TCY2 | In distribution | |
| TCS1000 | Total Volume 1000 ml | In distribution |
| TCS500DS | Total Volume 500 ml | In distribution |
| TCY2 | In distribution | |
| TCS500DS | Total Volume 500 ml | In distribution |
| TCS1000 | Total Volume 1000 ml | In distribution |
| TCS500DS | Total Volume 500 ml | In distribution |
| TCS500D | Total Volume 500 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 169 |
| Cardinal Health | Cardinal Health 200, LLC | 50 |
| Closed Suction | Sunset Healthcare Solutions, Inc. | 49 |
| Closed Wound Suction | C.R. Bard, Inc. | 37 |
| Barovac® Evacuator Closed Wound Drainage System(SS) | Sewoon Medical Co., Ltd. | 33 |
| Hemovac® Wound Drainage System | Zimmer Orthopaedic Surgical Products | 23 |
| Barovac® Evacuator Closed Wound Drainage System(PP) | Sewoon Medical Co., Ltd. | 22 |
| Deluxe Closed Suction System 72hr | Sunset Healthcare Solutions, Inc. | 20 |
| Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 19 |
| Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 18 |
| S-Vac® Fluted Channel Drain | Aspen Surgical Products, Inc. | 17 |
| Aspen® Discrete Drain | Aspen Surgical Products, Inc. | 16 |
Showing 12 of 110. All products under Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K863562 | 1986-09-29 |
| K863505 | 1986-09-18 |
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.