SleepWeaver Advance Pediatric – Mask & Headgear – Blue
The SleepWeaver Advance Pediatric mask provides a nasal interface for prescribed noninvasive positive airway pressure therapy in children aged 2 to 7. It is intended for single-patient use…
The SleepWeaver Advance Pediatric mask provides a nasal interface for prescribed noninvasive positive airway pressure therapy in children aged 2 to 7. It is intended for single-patient use at home or in a hospital or institution. Adjustable elastic headgear holds its cloth cushion over the child’s nose.
A swivel connector attaches the mask to standard 22 mm air tubing from the therapy device. The patient breathes through the mask while continuous airflow carries exhaled carbon dioxide out through exhalation holes incorporated into the cloth cushion.
Listed Item
SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear – Blue
Cleaning and Materials
The blue cushion is polyester with a polyester, nylon, Lycra and polyurethane interface. The tubing swivel rotates through 360 degrees and can be detached for cleaning or cushion replacement. The headgear is also removable for cleaning and replacement.
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 | Circadiance, United States |
|---|---|
| FDA product code | BZD |
| Device type | Ventilator, Non-Continuous (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K151683 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101325 | 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 |
| Yuwell Sleep Apnea Breathing Therapy Mask | Suzhou Yuyue Medical Technology Co., Ltd. | 76 |
| AF541 | Respironics Inc. | 71 |
| CPAP Masks | Sunset Healthcare Solutions, Inc. | 69 |
Showing 12 of 699. All products under Ventilator, Non-Continuous (Respirator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162905 | 2017-03-15 |
| K151683 | 2016-04-05 |
| K130481 | 2013-05-24 |
| K120757 | 2012-04-24 |
| K092362 | 2009-11-02 |
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.