Medline
Compressor,nebulizer,w/Carry Bag,pediatr
23manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | BTI |
| Device type | Compressor, Air, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.6250 |
| 510(k) | K031413 |
| Record published | 2020-10-28 |
| Record revised | 2025-09-24 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Protect from freezing and avoid excessive heat. |
| Packaging | Case of 8, pack of 8, pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HCSPUPPY | In distribution | |
| HCS60004G | In distribution | |
| HCSOCCER | In distribution | |
| HCSFISHNEBRD | In distribution | |
| HCS70004C | In distribution | |
| HCS2GOBATT | In distribution | |
| HCSFISHSOL | In distribution | |
| HCS60004RD | In distribution | |
| HCS60004P | In distribution | |
| HCSOCCERSOL | In distribution | |
| HCS70004 | In distribution | |
| HCSDOGNEB2RD | In distribution | |
| HCSTURTLERD | In distribution | |
| HCS70004XP | In distribution | |
| HCS2GO | In distribution | |
| HCSDOGNEB2 | In distribution | |
| HCS70004ADLT | In distribution | |
| HCSTURTLESOL | In distribution | |
| HCS60004C | In distribution | |
| HCSOCCERD | In distribution | |
| HCSPUPPYSOL | In distribution | |
| HCSTURTLE | In distribution | |
| HCS60004BL | In distribution | |
| HCS70004RD | In distribution | |
| HCSLADYBUGSOL | In distribution | |
| HCSPUPPYXP | In distribution | |
| HCSOCCERXP | In distribution | |
| HCSFISHNEB | In distribution |
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 |
| 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 |
| Medquip | Drive DeVilbiss Healthcare | 9 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K031686 | 2004-01-21 |
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.