Vortex
Vortex Nonelectrostatic Valved Holding Chamber w/ Toddler Mask
42manufacturers in China registered for this device type
15catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (23), Jiangsu (7), Fujian (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shenzhen BI-Rich Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Apex Medical (Kunshan) Corp. | Kunshan | Jiangsu | Contract manufacturer | 4 |
| Dongguan Polygreen Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Living Science Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 42. All 42 manufacturers in China registered for Nebulizer (Direct Patient Interface)
Record
| Listed by | Pari Respiratory Equipment, Inc., United States |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K020944 |
| Record published | 2017-03-02 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Carton of 12, carton of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 051F7200 | In distribution | |
| 051F8000 | In distribution | |
| 051F7500 | In distribution | |
| 051F8100 | In distribution | |
| 051F8300 | In distribution | |
| 051F6000 | In distribution | |
| 051F7000 | In distribution | |
| 051F5000 | In distribution | |
| 051H5400 | In distribution | |
| 051H7400 | In distribution | |
| 051F5110 | In distribution | |
| 051H8400 | In distribution | |
| 051F7100 | In distribution | |
| 051F5210 | In distribution | |
| 051F8200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 220 |
| AirLife | Carefusion | 77 |
| AirLife™ | Airlife, Inc. | 76 |
| Ventlab | Ventlab, LLC | 56 |
| I-neb | Respironics Respiratory Drug Delivery (Uk), Ltd. | 55 |
| Aerogen® Solo Nebulizer System | Aerogen Ltd | 53 |
| Portex | ICU Medical, Inc | 50 |
| Sidestream | Respironics Respiratory Drug Delivery (Uk), Ltd. | 48 |
| Hudson RCI | Medline Industries, Inc. | 46 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 45 |
| Drive | Drive DeVilbiss Healthcare | 42 |
| Drivemedical | Drive DeVilbiss Healthcare | 40 |
Showing 12 of 541. All products under Nebulizer (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251572 | 2025-12-19 |
| K223840 | 2023-08-11 |
| K191270 | 2020-01-23 |
| K162785 | 2017-04-14 |
| K112859 | 2012-05-30 |
| K092560 | 2010-05-06 |
| K100380 | 2010-02-22 |
| K092918 | 2010-02-04 |
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.