Airlife™ Bubble Humidifier With 6 Psi Pressure Relief Valve
Catalogue number 002006, listed by Vyaire Medical, Inc., United States, under Humidifier, Respiratory Gas, (Direct Patient Interface). 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (2), Fujian (1). 9 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 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Chinamed Products (China) Ltd. | Gaoyao District | Guangdong | Manufacturer | 8 |
| Ninghai Guangjie Electronic Commerce Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 3 |
| Vincent Medical(Dongguan)Technology Company Limited | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Vyaire Medical, Inc., United States |
|---|---|
| FDA product code | BTT |
| Device type | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5450 |
| Record published | 2020-01-15 |
| Record revised | 2024-07-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 002006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 160 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 151 |
| Vapotherm | Vapotherm Inc. | 134 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | Salter Labs | 96 |
| Hudson RCI | Medline Industries, Inc. | 41 |
| AirLife™ | Airlife, Inc. | 27 |
| Fisher and Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 20 |
| F&P Optiflow Junior 2 | Fisher & Paykel Healthcare, Ltd. | 17 |
| MR850 | Fisher & Paykel Healthcare, Ltd. | 13 |
| AirLife | Carefusion | 13 |
| softFlow | TNI Medical AG | 11 |
| F&P Optiflow+ | Fisher & Paykel Healthcare, Ltd. | 7 |
Showing 12 of 138. All products under Humidifier, Respiratory Gas, (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231380 | 2023-08-10 |
Recalls
4 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-11-29 | Class I | Process control | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventila | 16,670 units in total | 2021-02-05 |
| 2014-11-29 | Class I | Process control | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventila | 16,670 units in total | 2021-02-05 |
| 2014-11-29 | Class I | Process control | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventila | 16,670 units in total | 2021-02-05 |
| 2014-11-29 | Class I | Process control | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventila | 16,670 units in total | 2021-02-05 |
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.