Portex
9 catalogue numbers from 225-3524-804, listed by ICU Medical, Inc, United States, under Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase. 29 manufacturers in China are registered for this product code.
29manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (17), Jiangsu (5), Zhejiang (3). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 29. All 29 manufacturers in China registered for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | CCK |
| Device type | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K910509 |
| Record published | 2016-10-11 |
| Record revised | 2025-04-17 (version 9) |
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 |
| Packaging | Carton of 50, box of 25, carton of 250, bag of 20, carton of 15, carton of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 225-3524-804 | In distribution | |
| 8530C-25 | In distribution | |
| C45101816D-NL | In distribution | |
| C45091538D-NL | In distribution | |
| C45091530D-NL | In distribution | |
| 225-3523-804 | In distribution | |
| C45101817D-NL | In distribution | |
| 650904 | In distribution | |
| VP1340 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Salter Labs | 241 |
| Microstream | Oridion Medical 1987 Ltd. | 92 |
| Hudson RCI | Teleflex Medical LLC | 79 |
| Medline | Medline Industries, Inc. | 65 |
| BCI | ICU Medical, Inc | 64 |
| Curaplex | Bound Tree Medical, LLC | 60 |
| Microstream Advance | Oridion Medical 1987 Ltd. | 51 |
| Ventlab | Ventlab, LLC | 42 |
| Vital Signs | Carefusion Finland 320 Oy | 33 |
| AirLife™ | Airlife, Inc. | 32 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Nihon Kohden Corp. | 23 |
| Curaplex | TRI-Anim Health Services, Inc. | 23 |
Showing 12 of 441. All products under Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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 Pm, Inc. | 510(k) number | 2010-01-15 | Not classified | Nonconforming Material/Component | Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Vet | 1358 cords for all devices (1032 US, 326 OUS) (871 Human, 48 | 2012-03-14 |
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.