AirLife™
AirLife™ Ventilator Circuit With Parallel Patient "Y" and 1/8" and 1/4" Pressure Lines For use with ventilators that have internal exhalation valves
4manufacturers in China registered for this device type
110catalogue numbers in this listing
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 | Airlife, 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 |
| 510(k) | K915226 |
| Record published | 2021-04-02 |
| Record revised | 2026-02-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -20 to 50 °C; Handling environment humidity 0 to 85 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Special storage condition: Keep away from sunlight |
| Packaging | Case of 20, case of 10, case of 30, case of 50, case of 1000, 10 of 10 |
| Sizes | Length 4 to 12 ft |
| Distribution end date | 2026-05-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10225-504 | In distribution | |
| 1853-503 | In distribution | |
| 4864-504 | In distribution | |
| AH102 | In distribution | |
| AH032 | In distribution | |
| 10794-H12 | In distribution | |
| 9073-HS7 | In distribution | |
| RT607-853 | In distribution | |
| 428040008 | In distribution | |
| 10828-701 | In distribution | |
| 6800-503 | In distribution | |
| 6462-H08 | In distribution | |
| 10771-H12 | In distribution | |
| 4377-H10 | In distribution | |
| 1005-H05 | Length 5 ft | In distribution |
| 37748CE | In distribution | |
| 10155N-504 | In distribution | |
| 5900-504 | In distribution | |
| 1600-701 | Length 6 ft | In distribution |
| 0P1776 | In distribution | |
| RT500-853 | In distribution | |
| 6460-H12 | In distribution | |
| 5550-504 | In distribution | |
| 4642-504 | In distribution | |
| 37756CE | In distribution | |
| 10155N-504 | In distribution | |
| AH119 | In distribution | |
| 10538-504 | In distribution | |
| 4947-504 | In distribution | |
| AH165 | In distribution | |
| RC6Y023034 | In distribution | |
| 10333-504 | In distribution | |
| 9074-HS3 | In distribution | |
| 10471-504 | In distribution | |
| 10746-855 | In distribution | |
| 9064-HS7 | In distribution | |
| AH165 | In distribution | |
| 4642-504 | In distribution | |
| 10333-504 | In distribution | |
| 4947-504 | In distribution | |
| 10608-701 | In distribution | |
| 5979-504 | In distribution | |
| 37723CE | In distribution | |
| RC60005073 | In distribution | |
| 9076-701 | Length 4 ft | In distribution |
| RT609-858 | In distribution | |
| 6460-H12 | In distribution | |
| 10828-701 | In distribution | |
| 7104-HS7 | In distribution | |
| AH032 | In distribution | |
| 6800-503 | In distribution | |
| 1006-H05 | In distribution | |
| 5898-503 | Length 6 ft | In distribution |
| 4377-H10 | In distribution | |
| 37735CE | In distribution | |
| 10281-855 | In distribution | |
| 37736CE | In distribution | |
| 10303N-504 | In distribution | |
| RC60002081 | In distribution | |
| 7331-HS5 | In distribution | |
| 7384-HS7 | In distribution | |
| 10836-504 | In distribution | |
| 10569-HS5 | In distribution | |
| 10281-855 | In distribution | |
| 10604-855 | In distribution | |
| 1006-H05 | In distribution | |
| 10296-504 | In distribution | |
| 4681-504 | Length 8 ft | In distribution |
| RT600-850 | In distribution | |
| 6907-701 | Length 12 ft | In distribution |
| 10471-504 | In distribution | |
| 1853-503 | In distribution | |
| 10192-HS3 | In distribution | |
| 10799-H12 | In distribution | |
| 10746-855 | In distribution | |
| RT409-852 | In distribution | |
| 37747CE | In distribution | |
| 10538-504 | In distribution | |
| 1206-701 | In distribution | |
| 10608-701 | In distribution | |
| 10779-504 | In distribution | |
| 9066-HS7 | In distribution | |
| 4864-504 | In distribution | |
| 5753-H10 | In distribution | |
| 37712CE | In distribution | |
| 10225-504 | In distribution | |
| 6814-H12 | In distribution | |
| 10856-H08 | In distribution | |
| 9065-HS7 | In distribution | |
| 10604-855 | In distribution | |
| 10863-H12 | Length 7 ft | In distribution |
| 1997-504 | In distribution | |
| RT509-852 | In distribution | |
| RC60002055 | In distribution | |
| 6462-H08 | In distribution | |
| 6463-H08 | In distribution | |
| AH180 | In distribution | |
| RT607-854 | In distribution | |
| RT609-855 | In distribution | |
| 1212-H11 | In distribution | |
| RT609-856 | In distribution | |
| 37756C | In distribution | |
| 6461-H12 | In distribution | |
| AH180 | In distribution | |
| AH102 | In distribution | |
| 10726-H05 | In distribution | |
| 1206-701 | In distribution | |
| 10559-855 | Withdrawn | |
| 1209-503 | Length 4 ft | Withdrawn |
| 10855-855 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Vyaire Medical, Inc. | 510(k) number | 2025-04-10 | Class I | Component design/selection | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure. | 1895 | |
| Vyaire Medical, Inc. | 510(k) number | 2025-04-10 | Class I | Component design/selection | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure. | 3053 | |
| Carefusion 2200, Inc. | 510(k) number | 2014-07-31 | Class II | No Marketing Application | The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas | Approximately 318,280 devices | 2016-02-08 |
| Carefusion 2200, Inc. | 510(k) number | 2012-05-29 | Class I | Equipment maintenance | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. | 2016-01-22 | |
| Carefusion 2200, Inc. | 510(k) number | 2012-05-29 | Class I | Equipment maintenance | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. | 2016-01-22 | |
| Carefusion 2200, Inc. | 510(k) number | 2012-05-29 | Class I | Equipment maintenance | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. | 2016-01-22 |
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.