AirLife
AirLife Infant Single Limb Heated Wire Circuit single-limb, single-heat, continuous-flow circuit (>4 L/min)
4manufacturers in China registered for this device type
107catalogue 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 | Carefusion, 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 | Specification developer, Manufacturer |
| 510(k) | K151959 |
| Record published | 2016-09-01 |
| Record revised | 2024-05-22 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20, case of 10, case of 30, case of 500, case of 1000 |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4377-H10 | Withdrawn | |
| 10303N-504 | Withdrawn | |
| 9061-HS7 | Withdrawn | |
| 10195-HS3 | Withdrawn | |
| 10155N-504 | Withdrawn | |
| RC6Y104003 | Withdrawn | |
| 10799-H12 | Withdrawn | |
| AH132 | Withdrawn | |
| 9026-HS7 | Withdrawn | |
| 1997-504 | Withdrawn | |
| AH102 | Withdrawn | |
| 1006-H05 | Withdrawn | |
| AH032 | Withdrawn | |
| 7149-HS7 | Withdrawn | |
| RT507-853 | Withdrawn | |
| 7331-HS5 | Withdrawn | |
| 4809-703 | Withdrawn | |
| RT610-853 | Withdrawn | |
| 10846-H05 | Withdrawn | |
| 4681-504 | Withdrawn | |
| RT607-853 | Withdrawn | |
| 10505-HS3 | Withdrawn | |
| 1200-H08 | Withdrawn | |
| RC6Y006095 | Withdrawn | |
| 9024-HS7 | Withdrawn | |
| 10771-H12 | Withdrawn | |
| 7166-HS7 | Withdrawn | |
| 7519-HS3 | Withdrawn | |
| 1005-H05 | Withdrawn | |
| 4714-461 | Withdrawn | |
| 7105-HS7 | Withdrawn | |
| 5962-504 | Withdrawn | |
| 428040008 | Withdrawn | |
| 6556-H12 | Withdrawn | |
| 9066-HS7 | Withdrawn | |
| AH165 | Withdrawn | |
| 10815-HS7 | Withdrawn | |
| 10333-504 | Withdrawn | |
| 7418-HS3 | Withdrawn | |
| RT510-853 | Withdrawn | |
| 4947-504 | Withdrawn | |
| 10709-H08 | Withdrawn | |
| 6489-504 | Withdrawn | |
| RT600-850 | Withdrawn | |
| RC60002055 | Withdrawn | |
| 10856-H08 | Withdrawn | |
| 7183-HS7 | Withdrawn | |
| RC60002081 | Withdrawn | |
| 9073-HS7 | Withdrawn | |
| 7384-HS7 | Withdrawn | |
| 6073-504 | Withdrawn | |
| 7102-HS7 | Withdrawn | |
| 9074-HS3 | Withdrawn | |
| RC6Y006098 | Withdrawn | |
| AH265 | Withdrawn | |
| 6621-504 | Withdrawn | |
| 10635-H12 | Withdrawn | |
| 1212-H11 | Withdrawn | |
| RT509-852 | Withdrawn | |
| 7155-HS3 | Withdrawn | |
| 6846-H12 | Withdrawn | |
| RT607-854 | Withdrawn | |
| 10578-HS5 | Withdrawn | |
| RC6P003059 | Withdrawn | |
| 10569-HS5 | Withdrawn | |
| 10538-504 | Withdrawn | |
| 1838-H08 | Withdrawn | |
| 6454-504 | Withdrawn | |
| 10225-504 | Withdrawn | |
| 6460-H12 | Withdrawn | |
| 1704-H07 | Withdrawn | |
| 9072-HS7 | Withdrawn | |
| 5753-H10 | Withdrawn | |
| 10794-H12 | Withdrawn | |
| AH180 | Withdrawn | |
| 6678-H08 | Withdrawn | |
| 10808-H12 | Withdrawn | |
| RT500-853 | Withdrawn | |
| 7148-HS3 | Withdrawn | |
| 6461-H12 | Withdrawn | |
| RT609-856 | Withdrawn | |
| RT609-855 | Withdrawn | |
| 6934-504 | Withdrawn | |
| 9065-HS7 | Withdrawn | |
| RC5Y002005 | Withdrawn | |
| 7104-HS7 | Withdrawn | |
| 10564-HS5 | Withdrawn | |
| 7273-HS5 | Withdrawn | |
| RC6Y023034 | Withdrawn | |
| 6463-H08 | Withdrawn | |
| 7378-HS7 | Withdrawn | |
| 4253-H12 | Withdrawn | |
| 10863-H12 | Withdrawn | |
| 10726-H05 | Withdrawn | |
| 10311-HS5 | Withdrawn | |
| RC60005073 | Withdrawn | |
| 1004-H05 | Withdrawn | |
| 1658-854 | Withdrawn | |
| 10192-HS3 | Withdrawn | |
| 9037-HS7 | Withdrawn | |
| 6814-H12 | Withdrawn | |
| RT409-852 | Withdrawn | |
| 10653-H08 | Withdrawn | |
| RC6Y006094 | Withdrawn | |
| 6462-H08 | Withdrawn | |
| 7142-HS7 | Withdrawn | |
| 9064-HS7 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AirLife™ | Airlife, Inc. | 110 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153234 | 2016-07-07 |
| K151959 | 2016-01-20 |
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.