Pedi-Neb™
Pedi-Neb™ Small Volume Nebulizer, Pacifier with Adaptor
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 | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K800562 |
| Record published | 2025-12-19 |
| Record revised | 2026-06-03 (version 2) |
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 |
| Packaging | Box of 12, box of 25 |
| Distribution end date | 2026-06-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0382 | In distribution | |
| 0383 | In distribution | |
| 0385 | In distribution | |
| 3655PN-612 | Withdrawn |
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)
Recalls
2 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 |
|---|---|---|---|---|---|
| 2016-01-05 | Class II | Nonconforming Material/Component | Reports that the T-piece does not fit on the nebulizer. | 70 units | 2016-04-21 |
| 2015-08-04 | Class II | Component change control | The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment. | 8,975 | 2016-05-06 |
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.