Easy Air Mini Sinus Irrigation System
The Nasal irrigator is used to clean mucus from nasal passage making medication more effective. It can also help to clean allergens, irritants, bacteria and viruses from the nose, reducing…
The Nasal irrigator is used to clean mucus from nasal passage making medication more effective. It can also help to clean allergens, irritants, bacteria and viruses from the nose, reducing the frequency of infection as well as decreasing swelling in the nose and increasing air flow.
Who Else Makes It
Concentrated in Guangdong (37), Zhejiang (10), Jiangsu (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Cotronic Technology Limited | Shenzhen, Guang Dong | Guangdong | Contract manufacturer | 5 |
| Shantou City KIN Seng Plastic Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
Showing 12 of 63. All 63 manufacturers in China registered for Irrigator, Powered Nasal
Record
| Listed by | Home Aide Diagnostics, Inc., United States |
|---|---|
| FDA product code | KMA |
| Device type | Irrigator, Powered Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5550 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2019-09-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment temperature 50 to 104 °F; Handling environment humidity 10 to 95 % RH; Storage environment temperature -20 to 70 °C; Storage environment temperature -4 to 158 °F; Storage environment humidity 10 to 95 % RH |
| Packaging | Outer carton of 32 |
| Sizes | Total volume 100 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NI-50 | Total Volume 100 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hydrodebrider® | Medtronic Xomed, Inc. | 9 |
| SinuPulse | Health Solutions Medical Products, Corp. | 4 |
| iHealth | iHealth Labs, Inc. | 3 |
| Naväge | Rhinosystems, Inc. | 3 |
| Berrcom | Guangzhou Berrcom Medical Device Co., Ltd. | 3 |
| InhwRior | Shenzhen Yuechuan Trade Co., Ltd. | 2 |
| Braun | KAZ USA, Inc. | 2 |
| HealthSmart | D-M-S Holdings, Inc. | 2 |
| Bios Diagnostics | Thermor Ltd. | 2 |
| Cleaning sheath for Ø3.1mm X 170mm 45° R | Henke-Sass Wolf, Gmbh. | 1 |
| Cleaning sheath for Ø3.1mm X 170mm 0° | Henke-Sass Wolf, Gmbh. | 1 |
| Cleaning sheath for Ø4mm X 155mm 45° | Henke-Sass Wolf, Gmbh. | 1 |
Showing 12 of 36. All products under Irrigator, Powered Nasal
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.