Yuwell Sleep Apnea Breathing Therapy Mask
Yuwell Sleep Apnea Breathing Therapy Masks connect a patient to a CPAP or bilevel airway-pressure device. The family includes full-face, nasal and nasal-pillow configurations, with a frame,…
Yuwell Sleep Apnea Breathing Therapy Masks connect a patient to a CPAP or bilevel airway-pressure device. The family includes full-face, nasal and nasal-pillow configurations, with a frame, sealing cushion, elbow, swivel and headgear.
The frame supports the cushion and the headgear secures the mask. The elbow provides an exhaust path, and the rotating swivel connects to compatible breathing tubing without fixing its orientation.
Listed Item
YF-02 Full Face Mask Pack, include one frame, one headgear and three cushions (Small, Medium, Large), for single-patient use.
Use and Assembly
The masks can be disassembled without tools. They are intended for patients weighing more than 30 kg, with single-patient reuse at home and single-patient use in hospitals or institutions. The positive airway-pressure device supplies the airflow; the mask forms the patient interface.
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (2), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Hunan Beyond Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 3 |
| Shanghai Baron Technologies Co Ltd | Shanghai | Shanghai | Contract manufacturer | 3 |
| BMC(Dongguan) Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Zhejiang Baron Technologies Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Resvent Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Showing 12 of 18. All 18 manufacturers in China registered for Ventilator, Non-Continuous (Respirator)
Record
| Listed by | Suzhou Yuyue Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K203347 |
| Record published | 2023-11-14 |
| Record revised | 2022-11-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 50, carton of 10, pack of 20, pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| YF-02 Parts (S) | In distribution | |
| YN-02 (M) | In distribution | |
| YN-02 (L) | In distribution | |
| YN-03 Cushion (XL) | In distribution | |
| YN-02 Cushion (M) | In distribution | |
| YN-03 (L) | In distribution | |
| YN-03 Frame assembly | In distribution | |
| YF-01 (M) | In distribution | |
| YF-01 Cushion (S) | In distribution | |
| YF-02 Parts (M) | In distribution | |
| YN-03 (SML) | In distribution | |
| YN-02 (L) | In distribution | |
| YF-01 (S) | In distribution | |
| YF-02 (XL) | In distribution | |
| YN-02 (S) | In distribution | |
| YP-01 Cushion (L) | In distribution | |
| YN-03 (XL) | In distribution | |
| YN-02 (M) | In distribution | |
| YP-01 Cushion (S) | In distribution | |
| YP-01 Cushion (L) | In distribution | |
| YF-02 (L) | In distribution | |
| YN-02 Cushion (S) | In distribution | |
| YF-02 Frame | In distribution | |
| YF-02 Cushion (S) | In distribution | |
| YF-01 Cushion (L) | In distribution | |
| YN-03 Parts (S) | In distribution | |
| YF-02 Cushion (L) | In distribution | |
| YN-03 Cushion (XL) | In distribution | |
| YF-03 (S) | In distribution | |
| YF-02 Cushion (XL) | In distribution | |
| YN-03 Parts (L) | In distribution | |
| YN-03 Cushion (S) | In distribution | |
| YN-03 Cushion (S) | In distribution | |
| YF-01 (L) | In distribution | |
| YN-02 Cushion (L) | In distribution | |
| YF-02 Cushion (L) | In distribution | |
| YF-02 Cushion (M) | In distribution | |
| YF-01 (L) | In distribution | |
| YP-01 (SML) | In distribution | |
| YN-03 (M) | In distribution | |
| YN-03 Frame | In distribution | |
| YN-03 (Fit pack) | In distribution | |
| YF-02 Swivel | In distribution | |
| YN-03 (S) | In distribution | |
| YF-01 Cushion (M) | In distribution | |
| YP-01 Frame | In distribution | |
| YF-02 (SML) | In distribution | |
| YF-02 (M) | In distribution | |
| YF-03 (M) | In distribution | |
| YF-02 (S) | In distribution | |
| YF-02 (M) | In distribution | |
| YF-02 (Fit pack) | In distribution | |
| YP-01 Cushion (M) | In distribution | |
| YN-03 Parts (M) | In distribution | |
| YF-02 Cushion (XL) | In distribution | |
| YN-03 Cushion (M) | In distribution | |
| YP-01 Parts (SML) | In distribution | |
| YN-03 Cushion (L) | In distribution | |
| YN-03 Cushion (M) | In distribution | |
| YF-02 Parts (XL) | In distribution | |
| YF-02 (L) | In distribution | |
| YN-03 (L) | In distribution | |
| YP-01 Cushion (S) | In distribution | |
| YP-01 Cushion (M) | In distribution | |
| YN-02 (S) | In distribution | |
| YF-01 (S) | In distribution | |
| YF-02 Parts (L) | In distribution | |
| YF-02 (S) | In distribution | |
| YP-01 (Fit pack) | In distribution | |
| YF-02 Cushion (S) | In distribution | |
| YF-01 (M) | In distribution | |
| YF-02 Cushion (M) | In distribution | |
| YN-03 (M) | In distribution | |
| YF-03 (L) | In distribution | |
| YN-03 (S) | In distribution | |
| YN-03 Cushion (L) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 386 |
| DreamWear | Respironics Inc. | 183 |
| REMstar System One 60 Series | Respironics Inc. | 163 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 152 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 136 |
| Ventilator, Non-Continuous (Respirator) | Hans Rudolph, Inc. | 115 |
| BiPAP System One 60 Series | Respironics Inc. | 105 |
| Ventilator, Non-Continuous (Respirator) | Salter Labs | 85 |
| BiTrac Select | Pulmodyne Inc. | 79 |
| AF541 | Respironics Inc. | 71 |
| CPAP Masks | Sunset Healthcare Solutions, Inc. | 69 |
| Hudson RCI | Teleflex Medical LLC | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203347 | 2021-07-02 |
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.