Thermalite Heated CPAP Tube
Thermalite Heated CPAP Tube connects a CPAP machine to the patient's interface and provides warmed or humidified breathing gases during adult noninvasive ventilation. It is compatible with…
Thermalite Heated CPAP Tube connects a CPAP machine to the patient’s interface and provides warmed or humidified breathing gases during adult noninvasive ventilation. It is compatible with Philips Respironics DreamStation 1 and DreamStation 2 heated humidifiers.
Heating controls the gas temperature to help retain water as vapor and reduce condensation inside the tube. The range is available in two-wire and three-wire configurations.
Listed Item
Heated CPAP Tube for DreamStation and DreamStation 2
Single-Patient Reuse
The tubing is intended for reuse by one patient at home or in clinical settings, including hospitals, sleep laboratories, institutions and subacute facilities. Compatibility with the specified humidifier system is part of its use.
Who Else Makes It
All of them in Guangdong. 3 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 |
| Dongguan Plastiflex Hose Technology Ltd | Dongguan | Guangdong | Contract manufacturer | 3 |
| Guang Dong EDA Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Exceleron Medical, LLC, United States |
|---|---|
| FDA product code | BZE |
| Device type | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5270 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K241268 |
| Record published | 2025-01-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CTUB-06H15DS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AirLife™ | Airlife, Inc. | 110 |
| AirLife | Carefusion | 107 |
| Hudson RCI | Teleflex Medical LLC | 13 |
| Hybernite | Plastiflex Group NV | 11 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 10 |
| Hudson RCI | Medline Industries, Inc. | 10 |
| Hybernite RT | Plastiflex Group NV | 9 |
| Vocsn Patient Breathing Package | Ventec Life Systems, Inc. | 7 |
| Filter | Westmed, Inc. | 6 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Intersurgical Ltd. | 6 |
| F&P Evaqua 2 | Fisher & Paykel Healthcare, Ltd. | 4 |
| Circuits | Respironics Inc. | 4 |
Showing 12 of 56. All products under Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241268 | 2024-08-02 |
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.