Filter, Bacterial, Breathing-Circuit
Inter-Therm Breathing Filter/HME With Port AND Catheter Mount
15manufacturers in China registered for this device type
25catalogue numbers in this listing
11510(k) clearances naming 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 | Intersurgical Ltd., United Kingdom |
|---|---|
| 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, Exporter |
| 510(k) | K092451 |
| Record published | 2016-09-24 |
| Record revised | 2025-02-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| 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 |
| Packaging | Pack of 50, pack of 40, pack of 20, pack of 70 |
| Distribution end date | 2023-06-19 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1341033S | In distribution | |
| 1331030S | In distribution | |
| 1831030 | In distribution | |
| 1541030 | In distribution | |
| 1941030 | In distribution | |
| 1344031S | In distribution | |
| 1690030 | In distribution | |
| 1344000S | In distribution | |
| 1344032S | In distribution | |
| 1790030 | In distribution | |
| 1341031S | In distribution | |
| 1745030 | In distribution | |
| 1341032S | In distribution | |
| 1906030 | In distribution | |
| 1344007S | In distribution | |
| 1441030 | In distribution | |
| 1944000 | In distribution | |
| 1344030S | In distribution | |
| 1942030 | In distribution | |
| 1644030 | In distribution | |
| 1544030 | In distribution | |
| 1332030S | Withdrawn | |
| 1341030S | Withdrawn | |
| 1844030 | Withdrawn | |
| 1841030 | Withdrawn |
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 |
|---|---|
| K223258 | 2023-06-15 |
| K141087 | 2015-02-12 |
| K121026 | 2012-11-02 |
| K092451 | 2010-10-29 |
| K092409 | 2010-03-10 |
| K032322 | 2004-05-13 |
| K024270 | 2003-06-24 |
| K990949 | 1999-06-15 |
| K983610 | 1999-04-30 |
| K925462 | 1993-05-21 |
| K911427 | 1991-08-26 |
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.