Medic
The Expiratory Filter Heater is designed to warm the surface of a filter used in the expiratory pathway of a breathing circuit. The device is intended to prolong filter efficiency by…
The Expiratory Filter Heater is designed to warm the surface of a filter used in the expiratory pathway of a breathing circuit. The device is intended to prolong filter efficiency by minimizing excessive condensation that can cause expiratory resistance. Adding a heated filtration system to a ventilator can also protect the exhalation system and currounding environment from contamination which prevents the spread of infectious diseases. The heater consists of an aluminum heating surface that is thermostatically controlled to maintain an ideal temperature.
Who Else Makes It
Concentrated in Guangdong (13), Jiangsu (2), Henan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Tutamen Metalwork Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 12 |
| Tianjin Zhengtian Medical Instrument Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 2 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Picard Healthcare Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Dongguan Quanding Medical Supplies Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Obestec Industrial Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 14 |
| Shenzhen Joose Beauty Electronic Co., Ltd. | Shen Zhen | Guangdong | Contract manufacturer | 13 |
| Linjiang (Holdings) Limited | Shangqiu | Henan | Private-label distributor | 11 |
| Zhongshan Kingdom Electrical Appliance Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 11 |
| Shenzhen Youmay Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Zhongshan Bisen Plastic Electronic Products Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 9 |
Showing 12 of 19. All 19 manufacturers in China registered for Unit, Heating, Powered
Record
| Listed by | Medic Trade Co., Ltd. |
|---|---|
| FDA product code | IRQ |
| Device type | Unit, Heating, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5950 |
| Premarket notification | Exempt |
| Record published | 2023-03-30 |
| Record revised | 2023-06-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M-OA-FH01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HydraTherm | Drive DeVilbiss Healthcare | 93 |
| Whitehall Thermalators | Whitehall Manufacturing Co | 91 |
| Thermasplint | Whitehall Manufacturing Co | 64 |
| Chattanooga | DJO, LLC | 27 |
| Moist Hot-Pack Unit | Karis Co., Ltd. | 16 |
| Lotion/Gel Warmer | Drive DeVilbiss Healthcare | 6 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 5 |
| Inion® Universal instruments | Inion OY | 4 |
| Soqi | Hsin TEN Health & Wealth INDUSTRY(HEFEI)Co., Ltd. | 4 |
| Resorb X | KLS-Martin L.P. | 3 |
| Vadi | Vadi Medical Technology Co., Ltd. | 3 |
| Level ONE | KLS-Martin L.P. | 2 |
Showing 12 of 28. All products under Unit, Heating, Powered
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.