Heated CPAP Tube for DreamStation Series and PR System One
The Sunset heated CPAP tube carries warmed breathing gas from a compatible humidifier to an adult patient receiving noninvasive ventilation. It is intended for single-patient reuse at home…
The Sunset heated CPAP tube carries warmed breathing gas from a compatible humidifier to an adult patient receiving noninvasive ventilation. It is intended for single-patient reuse at home and in clinical settings, including hospitals and sleep laboratories.
Heating wires in the tube wall warm the passing air to reduce condensation within the breathing circuit. A temperature sensor near the mask end helps regulate the heat. The tube is approximately six feet long with a 15 mm internal diameter.
Listed Item
Heated CPAP Tube for DreamStation Series and PR System One- 6ft Light Gray Smoothbore CPAP Tubing – Slim Style
Humidifier Compatibility
A proprietary connector with two locking tabs fits the Philips Respironics System One Heated Humidifier and DreamStation Heated Humidifier. The tube must be used with the compatible humidification system.
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 | Sunset Healthcare Solutions, Inc., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K201418 |
| Record published | 2024-03-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TUB006SSRP | 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 |
|---|---|
| K201418 | 2021-01-29 |
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.