Berrcom
3 catalogue numbers from NC007, listed by Guangzhou Berrcom Medical Device Co., Ltd., China, under Irrigator, Powered Nasal. 63 manufacturers in China are registered for this product code.
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 | Guangzhou Berrcom Medical Device Co., Ltd., China |
|---|---|
| FDA product code | KMA |
| Device type | Irrigator, Powered Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5550 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-06-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Cartoon of 50, cartoon of 40 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NC007 | In distribution | |
| NC005 | In distribution | |
| NC005 | 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 |
| 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 |
| Breathe Comfort | Slv Pharmaceuticals LLC | 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.