Portex
108 catalogue numbers from C45091507D-NL, listed by ICU Medical, Inc, United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
108catalogue numbers in this listing
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 | ICU Medical, Inc, United States |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K033008 |
| Record published | 2016-12-07 |
| Record revised | 2025-04-17 (version 6) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 20, carton of 15, box of 20, box of 15, box of 40, carton of 12 |
| Distribution end date | 2019-09-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C45091507D-NL | In distribution | |
| C45091555D-NL | In distribution | |
| 225-3719-804 | In distribution | |
| C1121 | In distribution | |
| C1109 | In distribution | |
| 002871 | In distribution | |
| C48201813D-NL | In distribution | |
| 480804 | In distribution | |
| C49101728D-NL | In distribution | |
| C1118 | In distribution | |
| 386000 | In distribution | |
| C45101808D-NL | In distribution | |
| 002863 | In distribution | |
| 370941 | In distribution | |
| 372007 | In distribution | |
| C45091613D-NL | In distribution | |
| 364002-NL | In distribution | |
| C1033J | In distribution | |
| 370928 | In distribution | |
| 20-0004 | In distribution | |
| 384000-NL | In distribution | |
| C1117 | In distribution | |
| C37091656-NL | In distribution | |
| C45091092D-NL | In distribution | |
| C49201731D-NL | In distribution | |
| C1034J | In distribution | |
| C45751638-NL | In distribution | |
| 450962-NL | In distribution | |
| 387000-NL | In distribution | |
| C45091603-NL | In distribution | |
| C45101796D-NL | In distribution | |
| 225-3717-800 | In distribution | |
| C49201693-NL | In distribution | |
| 386003 | In distribution | |
| C1105 | In distribution | |
| C1115 | In distribution | |
| C45031503D-NL | In distribution | |
| 384006-NL | In distribution | |
| C49201781D-NL | In distribution | |
| 450954-NL | In distribution | |
| C37091806D-NL | In distribution | |
| 225-3709-800 | In distribution | |
| C45091449D-NL | In distribution | |
| 386001 | In distribution | |
| C37091325J | In distribution | |
| C45091795D-NL | In distribution | |
| C45091742D-NL | In distribution | |
| 225-2862-799 | In distribution | |
| 450961-NL | In distribution | |
| C45091039-NL | In distribution | |
| C37371719-NL | In distribution | |
| C49091676D-NL | In distribution | |
| 370936 | In distribution | |
| 370956D | In distribution | |
| 364001-NL | In distribution | |
| 371821 | In distribution | |
| 490903-NL | In distribution | |
| 386000-NL | In distribution | |
| 450906 | In distribution | |
| 450956-NL | In distribution | |
| 225-3720-802 | In distribution | |
| C45091769-NL | In distribution | |
| C45751687-NL | In distribution | |
| C37091362 | In distribution | |
| 384004-NL | In distribution | |
| C37091657-NL | In distribution | |
| C37041643D-NL | In distribution | |
| 370936-NL | In distribution | |
| 366001-NL | In distribution | |
| 450960-NL | In distribution | |
| C1045J | In distribution | |
| C45091690D-NL | In distribution | |
| 670804 | In distribution | |
| 002863 | In distribution | |
| C45091452-NL | In distribution | |
| 450904 | In distribution | |
| C45091652D-NL | In distribution | |
| C45091614-NL | In distribution | |
| C37101141-NL | In distribution | |
| 366002-NL | In distribution | |
| C1111 | In distribution | |
| C37201807D-NL | In distribution | |
| 100/585/000 | In distribution | |
| 100/585/000N | In distribution | |
| 450963-NL | In distribution | |
| C45091238D-NL | In distribution | |
| VP1338 | In distribution | |
| C45091490D-NL | In distribution | |
| C1046J | In distribution | |
| C1078 | In distribution | |
| 384001-NL | In distribution | |
| C37091305J | In distribution | |
| 450955-NL | In distribution | |
| C37091804D-NL | In distribution | |
| VP1342 | In distribution | |
| C1042J | In distribution | |
| 482802 | In distribution | |
| C37091634D-NL | In distribution | |
| C37101763-NL | In distribution | |
| C45091793D-NL | In distribution | |
| C45101713D-NL | In distribution | |
| 451050-NL | In distribution | |
| 002900 | In distribution | |
| VP1331 | In distribution | |
| 420345 | Withdrawn | |
| 225-3710-824 | Withdrawn | |
| 370902-NL | Withdrawn | |
| 225-3710-815 | 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 |
| 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 31 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical International, Ltd. | 510(k) number | 2005-06-07 | Not classified | Other | Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label | 292 units | 2012-05-08 |
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.