Hudson RCI
Water, Concha, Ster, 1650 ML, STD Column
12manufacturers in China registered for this device type
41catalogue 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | BTT |
| Device type | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5450 |
| 510(k) | K141353 |
| Record published | 2025-03-24 |
| Record revised | 2025-09-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep dry. Keep away from sunlight. |
| Packaging | Case of 20, case of 10, case of 25, case of 50, case of 6, pl of 252 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HUD2415 | In distribution | ||
| HUD00601 | In distribution | ||
| HUD38570 | 6 | In distribution | |
| HUD2416 | In distribution | ||
| HUD3230 | In distribution | ||
| HUD241212 | In distribution | ||
| HUD38150 | In distribution | ||
| HUDRHP340U | 20 | In distribution | |
| HUD241213 | In distribution | ||
| HUD38210 | In distribution | ||
| HUD241501 | In distribution | ||
| HUD241222 | In distribution | ||
| HUD38560 | 6 | In distribution | |
| HUD38530 | 6 | In distribution | |
| HUD00040 | In distribution | ||
| HUD241224 | In distribution | ||
| HUD241103 | In distribution | ||
| HUD00640 | 10 | In distribution | |
| HUD38520 | 6 | In distribution | |
| HUD42500R | In distribution | ||
| HUD78030 | In distribution | ||
| HUD2410 | In distribution | ||
| HUD241223 | In distribution | ||
| HUD00301 | In distribution | ||
| HUD3260 | In distribution | ||
| HUD872DTPCS | In distribution | ||
| HUD00540 | 12 | In distribution | |
| HUD00501 | In distribution | ||
| HUD79032 | In distribution | ||
| HUD50025 | 2 | In distribution | |
| HUD50020 | In distribution | ||
| HUD241102 | In distribution | ||
| HUD241214 | In distribution | ||
| HUD42500 | In distribution | ||
| HUD241211 | In distribution | ||
| HUD42500RU | In distribution | ||
| HUD241101 | In distribution | ||
| HUD241221 | In distribution | ||
| HUD241104 | In distribution | ||
| HUD2414 | In distribution | ||
| HUD241210 | 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 |
| 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 |
| AnaPod | Westmed, Inc. | 7 |
Showing 12 of 138. All products under Humidifier, Respiratory Gas, (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230559 | 2023-10-26 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2019-12-13 | Class I | Device Design | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy. | 127293 devices | 2024-04-30 |
| Teleflex Medical LLC | 510(k) number | 2019-12-13 | Class I | Device Design | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy. | 95696 devices | 2024-04-30 |
| Teleflex Medical LLC | 510(k) number | 2015-04-01 | Class II | Nonconforming Material/Component | Customer complaints were received of power to the unit ceasing and the display going blank. | 7,228 units | 2025-03-05 |
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.