Omron A.I.R.S.Disposable Nebulizer Kit
.Disposable Nebulizer Kit with Filter
57manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (19), Guangdong (17), Jiangsu (8). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
Showing 12 of 57. All 57 manufacturers in China registered for Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Record
| Listed by | Omron Healthcare, Inc., United States |
|---|---|
| FDA product code | CCQ |
| Device type | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5640 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K870027 |
| Record published | 2017-05-17 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 10 to 40 °C; Storage environment temperature 50 to 104 °F; Handling environment temperature 10 to 40 °C; Handling environment temperature 50 to 104 °F |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9912 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Salter Labs | 67 |
| Salter Aire Elite | Salter Labs | 31 |
| LMA Atomization | Teleflex Medical LLC | 30 |
| silverfox | Silverfox Corporation Limited | 14 |
| MedSource Nebulizer | Medsource International, LLC | 11 |
| Curaplex | Bound Tree Medical, LLC | 7 |
| VixOne™ Nebulizer Kit | Canadian Hospital Specialties Ltd. | 6 |
| Hudson RCI | Teleflex Medical LLC | 6 |
| BR Surgical, LLC | BR Surgical LLC | 5 |
| 1A Chamber | Patejim S.R.L. | 5 |
| Fofo | Foshan Hongfeng Co., Ltd. | 5 |
| Mediox | Mediox Medical Service Ltd | 5 |
Showing 12 of 45. All products under Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | 510(k) number | 2011-03-25 | Not classified | Equipment maintenance | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. | 9000 all varieties | 2011-10-26 |
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.