InHealth Technologies; Blom-Singer
11 catalogue numbers from BE 1055EZ, listed by Freudenberg Medical, LLC, United States, under Condenser, Heat And Moisture (Artificial Nose). 29 manufacturers in China are registered for this product code.
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 | Freudenberg Medical, LLC, United States |
|---|---|
| FDA product code | BYD |
| Device type | Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5375 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-01 |
| Record revised | 2019-11-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5, pack of 30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BE 1055EZ | 6 | In distribution | |
| BE 6038-P | In distribution | ||
| BE 8025H | In distribution | ||
| BE 8026H | In distribution | ||
| BE 1055EZS | In distribution | ||
| BE 6039 | In distribution | ||
| BE 1060 | In distribution | ||
| BE 6038 | In distribution | ||
| BE 8000 | In distribution | ||
| BE 6039-P | In distribution | ||
| BE 1080 | 10 | 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 |
| Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 9 |
| Closed Suction System | VR Medical Technology Co., Ltd. | 7 |
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.