NV UM FFM
NV UM FFM SYS SML SHW
126manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (40), Guangdong (29), Jiangsu (23). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
Showing 12 of 126. All 126 manufacturers in China registered for Mask, Oxygen
Record
| Listed by | Resmed PTY Ltd., Australia |
|---|---|
| FDA product code | BYG |
| Device type | Mask, Oxygen |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5580 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-14 |
| Record revised | 2023-07-31 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment temperature -4 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60642 | In distribution | |
| 60644 | In distribution | |
| 60643 | In distribution | |
| 60636 | In distribution | |
| 60645 | In distribution | |
| 60646 | In distribution | |
| 60641 | In distribution | |
| 60639 | In distribution | |
| 60640 | In distribution | |
| 60647 | In distribution | |
| 60637 | In distribution | |
| 60638 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 87 |
| Mask, Oxygen | Salter Labs | 61 |
| Curaplex | TRI-Anim Health Services, Inc. | 34 |
| 7301 EAGLE1 | Hans Rudolph, Inc. | 33 |
| Curaplex | Bound Tree Medical, LLC | 33 |
| Roscoe | Drive DeVilbiss Healthcare | 32 |
| BF | Allied Medical LLC | 28 |
| Ventlab | Ventlab, LLC | 25 |
| Adsafe™ | American Diagnostic Corp. | 25 |
| 7302 EAGLE2 | Hans Rudolph, Inc. | 24 |
| Oxygen Mask | Well Lead Medical Co., Ltd. | 24 |
| AirLife™ | Airlife, Inc. | 21 |
Showing 12 of 302. All products under Mask, Oxygen
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.