Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Round Silicone Wound Drain with Trocar
58manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
8recalls on this 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GCY |
| Device type | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4680 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2023-06-02 (version 3) |
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 | Pack of 10 |
| Distribution end date | 2019-06-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0215031000 | Diameter: 0.1875 Inch | Withdrawn |
| 0215032000 | Diameter: 0.25 Inch | Withdrawn |
| 0215015000 | Diameter: 0.1875 Inch | Withdrawn |
| 0215114000 | Diameter: 0.125 Inch | Withdrawn |
| 0215089000 | Withdrawn | |
| 0215019000 | Diameter: 0.25 Inch | Withdrawn |
| 0215018000 | Diameter: 0.125 Inch | Withdrawn |
| 0215030000 | Diameter: 0.125 Inch | Withdrawn |
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 |
| Tru-Close Suction Drainage System | Uresil, LLC | 19 |
| 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 |
Showing 12 of 110. All products under Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K823284 | 1983-01-14 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-03-26 | Class II | Package design/selection | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging | 300 boxes (3,000 each) | 2015-12-31 |
| 2015-03-26 | Class II | Package design/selection | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging | 1,984 boxes (19,840 each) | 2015-12-31 |
| 2015-03-26 | Class II | Package design/selection | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging | 2,711 boxes (27,110 each) | 2015-12-31 |
| 2015-03-26 | Class II | Package design/selection | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging | 1,375 boxes (13,750 each) | 2015-12-31 |
| 2015-03-26 | Class II | Package design/selection | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging | 4 boxes (40 each) | 2015-12-31 |
| 2015-03-26 | Class II | Package design/selection | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging | 3,177 boxes (31,770 each) | 2015-12-31 |
| 2015-03-26 | Class II | Package design/selection | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging | 648 boxes (6,480 each) | 2015-12-31 |
| 2015-03-26 | Class II | Package design/selection | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging | 6,424 boxes (64,240 each) | 2015-12-31 |
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.