Drive
Respiratory Respiratory Disposables Product Description Ped Mask for 18260 and Adapter, 1/ea
42manufacturers in China registered for this device type
42catalogue numbers in this listing
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 | Drive DeVilbiss Healthcare, United States |
|---|---|
| FDA product code | CAF |
| Device type | Nebulizer (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Repacker / relabeller |
| 510(k) | K031413 |
| Record published | 2016-09-16 |
| Record revised | 2025-09-24 (version 8) |
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, serial number |
| Packaging | Pack of 6, pack of 50, pack of 10, pack of 20, pack of 12, pack of 8 |
| Distribution end date | 2024-07-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MQ5900 | In distribution | ||
| 18260 | In distribution | ||
| NEB KIT 500 | In distribution | ||
| MQ80L | In distribution | ||
| MQ8000-B | In distribution | ||
| NEB KIT 700 | In distribution | ||
| MQ5600 | In distribution | ||
| NEB KIT 600 | In distribution | ||
| MQ8000L | In distribution | ||
| MQ8000 | In distribution | ||
| MQ5700B | In distribution | ||
| MQ6005 | In distribution | ||
| 18450 | In distribution | ||
| MQ8000S | In distribution | ||
| MQ80M | In distribution | ||
| 18254 | In distribution | ||
| MQ80S | In distribution | ||
| MQ8000M | In distribution | ||
| MQ6006 | In distribution | ||
| MQ6000 | In distribution | ||
| MQ0385 | In distribution | ||
| MQ5501 | Withdrawn | ||
| CMS-18080 | Withdrawn | ||
| 18081-PBL | Withdrawn | ||
| 18040P-220 | Withdrawn | ||
| 18041-Y | Withdrawn | ||
| MQ6003NEU | Withdrawn | ||
| NEB KIT 501 | Withdrawn | ||
| MQ6002NEU | Withdrawn | ||
| MQ0911 | Withdrawn | ||
| MQ6008 | Withdrawn | ||
| 18260-PDMASK | Withdrawn | ||
| MQ6000 | Withdrawn | ||
| MQ5700 | 8 | Withdrawn | |
| 18090-BE-220 | Withdrawn | ||
| 800G | Withdrawn | ||
| MQ6003NEU | Withdrawn | ||
| MQ0050 | Withdrawn | ||
| MQ5600EU | Withdrawn | ||
| MQ5500 | Withdrawn | ||
| MQ0911EU | Withdrawn | ||
| MQ5300 | 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 |
| Drivemedical | Drive DeVilbiss Healthcare | 40 |
| Medline | Medline Industries, Inc. | 38 |
Showing 12 of 541. All products under Nebulizer (Direct Patient Interface)
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Sanrai International LLC | 510(k) number | 2018-08-29 | Class II | Device Design | The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off. | 150 units | 2020-06-12 |
| Compass Health Brands (Distribution Center) | 510(k) number | 2015-04-20 | Class II | Use error | Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. These warnings are to better inform end users of proper care when using and | 219,353 Manuals | 2016-10-25 |
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.