DAR
Adult-Pediatric Mechanical Filter HME with Catheter Mount,Large
29manufacturers in China registered for this device type
21catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | BYD |
| Device type | Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5375 |
| Premarket notification | Exempt |
| Record published | 2023-09-16 |
| Record revised | 2026-04-07 (version 9) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Fragile, Keep dry, This side up |
| Packaging | Case of 25, case of 50 |
| Distribution end date | 2022-03-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 354/5920 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5920 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5876 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5414 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5876 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5902 | Tidal Volume, 300-1500, ML; | In distribution |
| 354U5876 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5833 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5414 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5900 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5841 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5902 | Tidal Volume, 300-1500, ML; | In distribution |
| 353U5908 | Tidal Volume, 200-1000, ML; | In distribution |
| 353U19004 | In distribution | |
| 353S19046 | In distribution | |
| 354U5876 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5833 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5900 | Tidal Volume, 300-1500, ML; | In distribution |
| 354/5841 | Tidal Volume, 300-1500, ML; | In distribution |
| 353U5413 | Tidal Volume, 100-1000, ML; | In distribution |
| 354U19028 | Tidal Volume, 200-1500, ML; | Withdrawn |
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 |
| 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 |
| Closed Suction System | VR Medical Technology Co., Ltd. | 7 |
Showing 12 of 219. All products under Condenser, Heat And Moisture (Artificial Nose)
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2021-04-29 | Class II | Material/Component Contamination | The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization. | 10890 |
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.