Ombra 120v Table Top Compressor System
The OMBRA 120V Table Top Compressor supplies compressed air to a jet or pneumatic nebulizer. It is a prescription device for adults and children, used under healthcare professional…
The OMBRA 120V Table Top Compressor supplies compressed air to a jet or pneumatic nebulizer. It is a prescription device for adults and children, used under healthcare professional direction in the home, hospital or clinic.
An electric motor drives the compressor inside a plastic housing. The unit operates from a 120 volt, 60 Hz mains supply and delivers air to the connected nebulizer. Rubber skids support the tabletop housing.
Listed Item
OMBRA Table Top Compressor System (120V)
Air Supply
The compressor has an operating airflow of approximately 4.52 liters per minute and an operating pressure of 19.6 psi. It is supplied with replaceable air filters and is nonsterile, with use limited to one patient.
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 | Trudell Medical International, Canada |
|---|---|
| FDA product code | BTI |
| Device type | Compressor, Air, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.6250 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K131881 |
| Record published | 2016-09-24 |
| Record revised | 2020-04-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 6 |
| Distribution end date | 2025-11-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 105510 | 6 | Withdrawn | |
| 105510 | 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 |
| Medquip | Drive DeVilbiss Healthcare | 9 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 6 |
| MedPak | Lifeport, LLC. | 5 |
| Carex Health Brands | Drive DeVilbiss Healthcare | 5 |
Showing 12 of 101. All products under Compressor, Air, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131881 | 2013-10-24 |
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.