MC300® Nebulizer With Corrugated Tubing, Mouthpiece and Universal Tubing
The MC300 Nebulizer with Corrugated Tubing and Mouthpiece provides a patient interface that can be positioned away from the nebulizer. It is used to deliver prescribed aerosolized…
The MC300 Nebulizer with Corrugated Tubing and Mouthpiece provides a patient interface that can be positioned away from the nebulizer. It is used to deliver prescribed aerosolized medication to adults and children aged two years and older under a licensed healthcare provider’s care.
The corrugated tube connects the nebulizer to the patient interface. The MC300 generates the aerosol, and the tubing extends its delivery pathway to a mouthpiece or suitable mask. The assembled configuration provides aerosol during both inhalation and exhalation.
Use Settings
The device is intended for hospitals, clinics and home care. The corrugated tube accessory is provided nonsterile for disposable, single-patient use. Its function depends on use with the compatible MC300 nebulizer.
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 | Trudell Medical International, Canada |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K203400 |
| Record published | 2021-06-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 105557 | 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 |
|---|---|
| K203400 | 2021-06-14 |
| K200063 | 2020-07-17 |
| K173825 | 2018-05-02 |
| K173367 | 2018-02-28 |
| K123614 | 2013-03-11 |
| K090065 | 2009-04-09 |
| K080926 | 2008-08-12 |
| K053605 | 2006-02-27 |
| K032972 | 2004-01-14 |
| K982181 | 1999-01-08 |
| K982179 | 1998-09-17 |
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.