Jackson-Pratt
Surgical Reservoir Kit Round 19Fr 400ml With Trocar Silicone
58manufacturers in China registered for this device type
6catalogue numbers in this listing
12recalls 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 | Cardinal Health 200, 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 | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-27 |
| Record revised | 2024-10-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Case of 10, box of 10, case of 3, case, box |
| Distribution end date | 2024-10-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SU130-1010 | In distribution | |
| SU1301305D | In distribution | |
| SU1301305D | In distribution | |
| SU1301000D | In distribution | |
| SU130-1010 | Withdrawn | |
| SU1301000D | 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
Recalls
11 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 |
|---|---|---|---|---|---|
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2017-04-21 | Class II | Process design | Product’s seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | 2017-12-27 | |
| 2004-07-28 | Not classified | Other | The products labeled as sterile are not sterile. | 110 cases | 2005-02-10 |
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.