HME With Flex Tubes
Catalogue number 31161, listed by Meditera Tibbi Malzeme Sanayi VE Ticaret Anonim Sirketi, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product 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 | Meditera Tibbi Malzeme Sanayi VE Ticaret Anonim Sirketi |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| 510(k) | K192713 |
| Record published | 2025-07-09 |
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, expiry date |
| Storage | Storage environment temperature 5 to 40 °C; Storage environment humidity 15 to 70 % RH |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31161 | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| S & Mohr America, S.A. DE C.V. | 510(k) number | 2023-01-05 | Class III | Process control | Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is “22.07.2027” | 1,320 masks |
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.