Softflow
Protective Cap f. Oxygen Inlet White, softFlow, 5 Pieces
12manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
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 | TNI Medical AG, Germany |
|---|---|
| FDA product code | BTT |
| Device type | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5450 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2021-03-15 |
| Record revised | 2024-05-03 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment humidity 0 to 93 % RH; Handling environment temperature -29 to 70 °C; Storage environment humidity 0 to 93 % RH; Storage environment temperature -29 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40610021 | In distribution | |
| 40620600 | In distribution | |
| 40630002 | In distribution | |
| 40620040 | In distribution | |
| 40630001 | In distribution | |
| 40641108 | In distribution | |
| 40610200 | In distribution | |
| 40620061 | In distribution | |
| 40630013 | In distribution | |
| 40641107 | In distribution | |
| 40630005 | 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 |
| F&P Optiflow+ | Fisher & Paykel Healthcare, Ltd. | 7 |
| AnaPod | Westmed, Inc. | 7 |
Showing 12 of 138. All products under Humidifier, Respiratory Gas, (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180474 | 2018-10-18 |
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.