Heated CPAP Tube
Sunset Heated CPAP Tube warms breathing gases before they enter an adult patient's airway during noninvasive ventilation. The heated wire tube reduces condensation in the breathing circuit…
Sunset Heated CPAP Tube warms breathing gases before they enter an adult patient’s airway during noninvasive ventilation. The heated wire tube reduces condensation in the breathing circuit and is intended for reuse by a single patient.
The tube is 1.83 m long with a 15 mm internal diameter. A proprietary connector with two locking tabs provides compatibility with Philips Respironics System One and Dreamstation heated humidifiers.
Listed Item
Heater, Breathing System W/WO Controller (NOT Humidifier OR Nebulizer)
Use Settings
The tube may be used at home or in clinical settings, including hospitals, institutions, sleep laboratories and subacute care facilities. Its intended reuse remains limited to one patient in either setting.
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 | 2021-10-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TUB06HPR | 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.