LMA Atomization
MAD Nasal Atomization Device w/o 3cc Syringe
57manufacturers in China registered for this device type
30catalogue numbers in this listing
5recalls on this code
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 | Teleflex Medical LLC, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-31 |
| Record revised | 2024-03-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 4, box of 25, box of 4, bag in box of 50, box, bag-in-box or bib of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN915305 | In distribution | ||
| IPN915308 | In distribution | ||
| IPN056575 | 50 | In distribution | |
| IPN048833 | 5 | In distribution | |
| IPN049183 | In distribution | ||
| IPN915304 | In distribution | ||
| IPN056583 | In distribution | ||
| IPN048832 | 20 | In distribution | |
| IPN056581 | In distribution | ||
| IPN915303 | In distribution | ||
| IPN056579 | In distribution | ||
| IPN915306 | In distribution | ||
| IPN048830 | In distribution | ||
| IPN046388 | In distribution | ||
| IPN048733 | In distribution | ||
| IPN048829 | In distribution | ||
| IPN049182 | In distribution | ||
| IPN048827 | In distribution | ||
| IPN056580 | In distribution | ||
| IPN056582 | In distribution | ||
| IPN916119 | 1,000 | In distribution | |
| IPN048831 | 5 | In distribution | |
| IPN915307 | In distribution | ||
| IPN046390 | In distribution | ||
| IPN048734 | 50 | In distribution | |
| IPN048826 | In distribution | ||
| IPN056578 | In distribution | ||
| IPN048828 | In distribution | ||
| IPN048837 | 1,000 | In distribution | |
| IPN916121 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Salter Labs | 67 |
| Salter Aire Elite | Salter Labs | 31 |
| 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 |
| Jedmed | Jedmed Instrument Company | 4 |
Showing 12 of 45. All products under Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-10-27 | Class II | Process control | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 2,674,650 units in total | 2020-09-25 |
| 2016-10-27 | Class II | Process control | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 2,674,650 units in total | 2020-09-25 |
| 2016-10-27 | Class II | Process control | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 2,674,650 units in total | 2020-09-25 |
| 2016-10-27 | Class II | Process control | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 2,674,650 units in total | 2020-09-25 |
| 2016-10-27 | Class II | Process control | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 2,674,650 units in total | 2020-09-25 |
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.