Hybernite
11 catalogue numbers from 3BCL 1010 3B ComfortLine, listed by Plastiflex Group NV, Belgium, under Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
11catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Plastiflex Group NV, Belgium |
|---|---|
| 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 |
| Record published | 2016-09-15 |
| Record revised | 2022-07-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 36, pack of 15, pack of 25, pack of 54 |
| Distribution end date | 2028-07-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3BCL 1010 3B ComfortLine | In distribution | |
| Comfortline 3B | In distribution | |
| ComfortLine Heated Tubing | In distribution | |
| Hybernite ROC US | In distribution | |
| Hybernite HBT White | In distribution | |
| Hybernite HBT white US | In distribution | |
| HBT IntelliPAP | In distribution | |
| Hybernite ROC US | In distribution | |
| Replacement Comfortline Heated Tubing | In distribution | |
| Hybernite HBT US | In distribution | |
| Sleepbox Heated Tube | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AirLife™ | Airlife, Inc. | 110 |
| AirLife | Carefusion | 107 |
| Hudson RCI | Teleflex Medical LLC | 13 |
| 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 |
| 22MM Smoothbore Exhalation Valve Heated Wire Breathing System With Monitor Line | Intersurgical Ltd. | 2 |
Showing 12 of 56. All products under Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151461 | 2016-03-24 |
| K100104 | 2010-04-14 |
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.