Freevent XtraCare Mini White (5 Pcs)
Catalogue number 8008, listed by Atos Medical AB, Sweden, 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 | Atos Medical AB, Sweden |
|---|---|
| FDA product code | BYD |
| Device type | Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5375 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-04 |
| Record revised | 2024-11-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 42 °C; Special storage condition: Keep away from rain. Keep away from sunlight.; Storage environment temperature 36 to 108 °F |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8008 | 5 | 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)
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-03-29 | Class II | Device Design | Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma. | 225 boxes of 30 devices | 2022-02-17 |
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.