Medquip
RespiratoryNebs Product Description: CompactComprssrNeb,w/Handle,1/ea, 6/cv
23manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Nantong Kangjinchen Medical Equipment Co., Ltd. | Nantong | Jiangsu | Manufacturer | 17 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Showing 12 of 23. All 23 manufacturers in China registered for Compressor, Air, Portable
Record
| Listed by | Drive DeVilbiss Healthcare, United States |
|---|---|
| FDA product code | BTI |
| Device type | Compressor, Air, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.6250 |
| Establishment | Repacker / relabeller |
| 510(k) | K031413 |
| Record published | 2016-09-29 |
| Record revised | 2025-09-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Packaging | Pack of 6, pack of 8 |
| Distribution end date | 2019-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MQ6006 | Withdrawn | |
| MQ6008 | Withdrawn | |
| MQ7000 | Withdrawn | |
| MQ6004 | Withdrawn | |
| MQ5700 | Withdrawn | |
| MQ0911 | Withdrawn | |
| MQ5501 | Withdrawn | |
| MQ6003 | Withdrawn | |
| MQ5800 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InnoSpire Elegance | Respironics Respiratory Drug Delivery (Uk), Ltd. | 124 |
| InnoSpire Essence | Respironics Respiratory Drug Delivery (Uk), Ltd. | 37 |
| Medline | Medline Industries, Inc. | 28 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 19 |
| Drive | Drive DeVilbiss Healthcare | 18 |
| Timeter | Allied Medical LLC | 16 |
| DK50 DS | Ekom Spol. S R.O. | 11 |
| V8800 Critical Care Ventilator | Oricare Inc. | 10 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 6 |
| MedPak | Lifeport, LLC. | 5 |
| Carex Health Brands | Drive DeVilbiss Healthcare | 5 |
| C235 | Ekom Spol. S R.O. | 5 |
Showing 12 of 101. All products under Compressor, Air, Portable
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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.