HME Flex
HME with Flex Tube
29manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (10), Guangdong (8), Jiangsu (5). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Ningbo Boya Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 8 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 29. All 29 manufacturers in China registered for Condenser, Heat And Moisture (Artificial Nose)
Record
| Listed by | Pepper Medical, Inc., United States |
|---|---|
| FDA product code | BYD |
| Device type | Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5375 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-25 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HME-712-Flex | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 34 |
| Hudson RCI | Teleflex Medical LLC | 34 |
| Gibeck | Teleflex Medical LLC | 27 |
| iCOR | Teleflex Medical LLC | 23 |
| DAR | Covidien LP | 21 |
| AirLife™ | Airlife, Inc. | 20 |
| Medisize® | Medisize B.V. | 19 |
| AirLife™ | Vyaire Medical, Inc. | 13 |
| HME | Pepper Medical, Inc. | 11 |
| ThermoFlo® | Typenex Medical, LLC | 11 |
| InHealth Technologies; Blom-Singer | Freudenberg Medical, LLC | 11 |
| Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 9 |
Showing 12 of 219. All products under Condenser, Heat And Moisture (Artificial Nose)
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.