Transcend
33 catalogue numbers from EZEX System, listed by Somnetics International, Inc, United States, under Ventilator, Non-Continuous (Respirator). 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
33catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Somnetics International, Inc, 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) | K132127 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature -20 to 60 °C; Handling environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH |
| Packaging | System package |
| Sizes | Length 3.6 to 11.5 in; width 3.6 to 9.5 in; height 2.4 to 4.5 in; length 190 mm; width 95 to 105 mm; height 94 to 95 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EZEX System | Length 11.5 in | In distribution |
| Desktop Software | In distribution | |
| P8 Battery | In distribution | |
| 3 miniCPAP Auto System | Height 4.5 in | In distribution |
| Universal Hose Adapter | In distribution | |
| Micro CPAP | In distribution | |
| 365 miniCPAP System | Length 7.8 in | In distribution |
| 3 miniCPAP Auto Service Unit | Length 190 mm | In distribution |
| CPAP Unit | Height 95 mm | In distribution |
| Auto System | Length 11.5 in | In distribution |
| Micro CPAP | Height 2.4 in | In distribution |
| 3 miniCPAP System | Length 11.5 in | In distribution |
| Removable Heater Assembly | In distribution | |
| P10 Battery | In distribution | |
| P4 Battery | In distribution | |
| 3 miniCPAP Service Unit | Height 94 mm | In distribution |
| Filter Assembly | In distribution | |
| Micro PureFresh | In distribution | |
| 365 miniCPAP Service Unit | Height 4.5 in | In distribution |
| Water Reservoir | In distribution | |
| 365 miniCPAP Auto Service Unit | Length 7.8 in | In distribution |
| CPAP Starter System | Length 11.5 in | In distribution |
| EZEX Unit | Length 190 mm | In distribution |
| 365 miniCPAP Auto System | Height 4.5 in | In distribution |
| 3 miniCPAP TranSync Bluetooth Module | In distribution | |
| Micro PowerAway Battery | In distribution | |
| 365 miniCPAP TranSync Bluetooth Module | In distribution | |
| Auto Unit | Length 190 mm | In distribution |
| Air Inlet Filter | In distribution | |
| Heater Cartridge Wick | In distribution | |
| Mobile Power Adapter | In distribution | |
| Filter Media | In distribution | |
| Heater Cartridge Wick (6-Pack) | 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 |
|---|---|
| K180388 | 2018-11-30 |
| K132127 | 2013-10-17 |
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.