Option Home W/ Side Stream, Disposable Nebulizer
Nebulizer, Compressor, Option Home w/ Side Stream, Disposable
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| PRO-MED (Wuxi)IMP.& Exp.co., Ltd. | Wuxi | Jiangsu | Exporter | 24 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Feellife Health Inc. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Solid Toys IND. Ltd. | Boluo County, Huizhou,City | Guangdong | Contract manufacturer | 8 |
| Shanghai Wanbo Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 8 |
| Dongguan Rongrui-Century Science&Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Bona Pharma Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Dongguan City Sinoshine Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 3 |
Record
| Listed by | A-M Systems, United States |
|---|---|
| FDA product code | EPN |
| Device type | Pump, Nebulizer, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Option Home w/ Side Stream, Disposable Nebulizer – 166320 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tian Medical | Tian Medical Inc | 2 |
| Nebulizer, Hand Held, Tee Adapter | A-M Systems | 2 |
| Nebulizer, Hand Held | A-M Systems | 2 |
| Nebulizer, Hand Held, Tee Adapter, 84″ Tube | A-M Systems | 1 |
| Innospire Mini | A-M Systems | 1 |
| Nebulizer, Side Stream, Re-Usable | A-M Systems | 1 |
| Shenzhen Bona Pharma | Shenzhen Bona Pharma Technology Co., Ltd. | 1 |
| Nebulizer, Side Stream, Disposable | A-M Systems | 1 |
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.