Teleflex
Intranasal Atomization Device
57manufacturers in China registered for this device type
1catalogue number
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 | 2023-03-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 48, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN922102 | 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
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.