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Catalogue number Filtered Mouthpiece, cs/50, listed by Monaghan Medical Corp., United States, under Device, Rebreathing. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Henan (4), Zhejiang (3), Guangdong (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| PRO-MED (Wuxi)IMP.& Exp.co., Ltd. | Wuxi | Jiangsu | Exporter | 24 |
| Fofo Medical Co., Ltd. | Xiamen | Fujian | Exporter | 18 |
| Shaoxing Haitech Medical Products Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 13 |
| Shenzhen Osto Medical Technology Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 11 |
| Shandong Moonlight Electronics Tech Co., Ltd. | Weifang | Shandong | Manufacturer | 11 |
| Zhengzhou Olive Electronic Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
| Hangzhou Yilong Medical Equipment Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 2 |
| Zhengzhou Youtai Health Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 2 |
| Zhengzhou Zhongkemei Health Technology Co., Ltd. | Shangjie District | Henan | Remanufacturer | 2 |
Showing 12 of 13. All 13 manufacturers in China registered for Device, Rebreathing
Record
| Listed by | Monaghan Medical Corp., United States |
|---|---|
| FDA product code | BYW |
| Device type | Device, Rebreathing |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5675 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-25 |
| Record revised | 2023-08-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Pack of 50 |
| Distribution end date | 2023-08-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Filtered Mouthpiece, cs/50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mtehfyaf | Beijing Xingjian Yongzhen Technology Co., Ltd. | 3 |
| Device, Rebreathing | VBM Medizintechnik Gmbh | 3 |
| MedSource Rebreather Mask | Medsource International, LLC | 2 |
| Monaghan Medical Corporation | Monaghan Medical Corp. | 1 |
| ANEclear | Anecare LLC | 1 |
| Paediatric Mask; Newborn | VBM Medizintechnik Gmbh | 1 |
| Paediatric Mask; Child | VBM Medizintechnik Gmbh | 1 |
| Paediatric Mask; Infant | VBM Medizintechnik Gmbh | 1 |
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.