Aerosol & Nebs
Compressor Nebulizer Kit with Audlt Mask and Tubing
46manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (22), Guangdong (7), Jiangsu (6). 8 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 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Showing 12 of 46. All 46 manufacturers in China registered for Mask, Oxygen, Low Concentration, Venturi
Record
| Listed by | Sunset Healthcare Solutions, Inc., United States |
|---|---|
| FDA product code | BYF |
| Device type | Mask, Oxygen, Low Concentration, Venturi |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5600 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-15 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RES090DS | In distribution | |
| NEB200MASK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Venticaire Lite | Flexicare Medical Ltd. | 91 |
| Hudson RCI | Teleflex Medical LLC | 21 |
| Mask, Oxygen, Low Concentration, Venturi | Salter Labs | 16 |
| CPAP Kit | Sunset Healthcare Solutions, Inc. | 9 |
| Pegasus | Pegasus Research Corp. | 6 |
| Medline | Medline Industries, Inc. | 4 |
| Hanwell | Ningbo Hanyue Medical Technology Co., Ltd. | 3 |
| Lightning X Products,Inc | Wuxi Emsrun Technology Co., Ltd. | 2 |
| Venturi Mask Adult W/6 Diluters, W/7FT Tubing, 6 Inch Corrugate Tube | Besmed Health Business Corporation | 2 |
| Resp-O2 Venturi Select A Vent Elongated Mask | Dynarex Corp. | 2 |
| Resp-O2 Venturi Adjustable Dial Elongated Mask | Dynarex Corp. | 2 |
| Rhino Rescue | Wuxi Emsrun Technology Co., Ltd. | 2 |
Showing 12 of 68. All products under Mask, Oxygen, Low Concentration, Venturi
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.