Hydrocleanse™
Device 1960100 Sinus Wash System
27manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (6), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Hebei Youjie Medical Devices Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 18 |
| Dongguan Yipincheng Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 17 |
Showing 12 of 27. All 27 manufacturers in China registered for Irrigator, Sinus
Record
| Listed by | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | KAR |
| Device type | Irrigator, Sinus |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-08-09 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1960100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aesculap | Aesculap AG | 20 |
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| Avalign | Avalign Technologies, Inc. | 15 |
| Boss Instruments | Boss Instruments, Ltd. | 12 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
| Pilling | Teleflex Medical LLC | 10 |
| AED | National Advanced Endoscopy Devices, Inc. | 5 |
| GEN2 | Surgix Medical LLC | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| Millennium | Avalign Technologies, Inc. | 4 |
| InhwRior | Shenzhen Yuechuan Trade Co., Ltd. | 4 |
| Cannula | KLS-Martin L.P. | 3 |
Showing 12 of 24. All products under Irrigator, Sinus
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.