Paediatric Mask; Newborn
#0; 15 mm OD.
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 | VBM Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | BYW |
| Device type | Device, Rebreathing |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5675 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-25 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight and heat.; Special storage condition: Kepp dry. |
| Packaging | Pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 88-11-000 | #0; 15 mm O.D. | In distribution |
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; Child | VBM Medizintechnik Gmbh | 1 |
| Paediatric Mask; Infant | VBM Medizintechnik Gmbh | 1 |
| AE II BAN | Monaghan Medical Corp. | 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.