Hudson RCI
AQUA+F, HCH Bacterial /Viral Filter with Swivel
15manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (4), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| 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 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
Showing 12 of 15. All 15 manufacturers in China registered for Filter, Bacterial, Breathing-Circuit
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K961914 |
| Record published | 2016-09-16 |
| Record revised | 2022-10-24 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool and dry place, protect from light and ozone (no ultraviolet light, if applicable)Keep away from sunlight |
| Packaging | Case of 20, case of 30, case of 25, case of 50, carton of 20, box of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN042653 | In distribution | |
| IPN043769 | In distribution | |
| IPN048702 | In distribution | |
| IPN913727 | In distribution | |
| IPN042610 | In distribution | |
| IPN043835 | In distribution | |
| IPN913683 | In distribution | |
| IPN060009 | In distribution | |
| IPN029794 | In distribution | |
| IPN042611 | In distribution | |
| IPN916674 | In distribution | |
| IPN042652 | In distribution | |
| IPN043836 | In distribution | |
| IPN042608 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 405 |
| Pulmoguard | S D I Diagnostics Inc | 203 |
| Cardinal Health | Cardinal Health 200, LLC | 131 |
| DAR | Covidien LP | 110 |
| Portex | ICU Medical, Inc | 108 |
| Vital Signs™ | SunMed Group Holdings, LLC | 78 |
| Pentair | Pentair Filtration Solutions | 68 |
| Disposable Anesthesia Circuits | Westmed, Inc. | 68 |
| AirLife™ | AirLife Finland Oy | 43 |
| Ventlab | Ventlab, LLC | 40 |
| VBMax | A-M Systems | 39 |
| Vital Signs™ | AirLife Finland Oy | 38 |
Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112958 | 2012-09-21 |
Recalls
6 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 |
|---|---|---|---|---|
| 2022-08-29 | Class I | Under Investigation by firm | Incidents of device splitting or detaching during use | 60,500 units US |
| 2022-08-29 | Class I | Under Investigation by firm | Incidents of device splitting or detaching during use | 7 units |
| 2022-08-29 | Class I | Under Investigation by firm | Incidents of device splitting or detaching during use | 42 units |
| 2022-08-29 | Class I | Under Investigation by firm | Incidents of device splitting or detaching during use | 355 units |
| 2022-08-29 | Class I | Under Investigation by firm | Incidents of device splitting or detaching during use | 164 units |
| 2022-08-29 | Class I | Under Investigation by firm | Incidents of device splitting or detaching during use | 12 units |
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.