Pilling
10 catalogue numbers from IPN021294, listed by Teleflex Medical LLC, United States, under Irrigator, Sinus. 27 manufacturers in China are registered for this product code.
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KAR |
| Device type | Irrigator, Sinus |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2026-02-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN021294 | In distribution | |
| IPN021302 | In distribution | |
| IPN021293 | In distribution | |
| IPN021296 | In distribution | |
| IPN021301 | In distribution | |
| IPN021295 | In distribution | |
| IPN021299 | In distribution | |
| IPN021297 | In distribution | |
| IPN021300 | In distribution | |
| IPN021298 | 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 |
| 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 |
| Symmetry House | Aspen Surgical Products, Inc. | 2 |
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.