BCI
64 catalogue numbers from 9004000, 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
64catalogue 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) | K970209 |
| Record published | 2016-10-13 |
| Record revised | 2025-04-16 (version 9) |
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, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9004000 | In distribution | ||
| 8211 | 10 | In distribution | |
| 92M774325A | In distribution | ||
| 1102P | 10 | In distribution | |
| 1140M | 10 | In distribution | |
| 1179 | 2 | In distribution | |
| 9004051 | In distribution | ||
| WW8214 | 10 | In distribution | |
| 9048 | 2 | In distribution | |
| 920654220A | In distribution | ||
| WW1140 | 10 | In distribution | |
| 8217 | In distribution | ||
| 9004003 | In distribution | ||
| 1151 | 10 | In distribution | |
| 8044 | 10 | In distribution | |
| 920654335A | In distribution | ||
| 1128 | 10 | In distribution | |
| 3026 | In distribution | ||
| WW1130 | 10 | In distribution | |
| 3311L | In distribution | ||
| 9004005 | In distribution | ||
| WW3138 | 10 | In distribution | |
| 920654230A | In distribution | ||
| WW1100 | 10 | In distribution | |
| 8075 | In distribution | ||
| 9015 | In distribution | ||
| 9004050 | In distribution | ||
| 1163 | 50 | In distribution | |
| 3025 | In distribution | ||
| 920654235A | In distribution | ||
| WW8030 | 10 | In distribution | |
| WW3398NO | In distribution | ||
| 92M774325 | In distribution | ||
| 8208 | 10 | In distribution | |
| 9212A | In distribution | ||
| 3311 | In distribution | ||
| 3311 | In distribution | ||
| 1152 | 10 | In distribution | |
| 9191 | In distribution | ||
| 8400 | In distribution | ||
| 1105 | 10 | In distribution | |
| 8401 | In distribution | ||
| 1148 | 10 | In distribution | |
| 1149T | 10 | In distribution | |
| WW1124 | 10 | In distribution | |
| 9189 | 10 | In distribution | |
| 1140B | 10 | In distribution | |
| 8400D | In distribution | ||
| 9216 | In distribution | ||
| 9004007 | In distribution | ||
| 9004001 | In distribution | ||
| WW1131 | 10 | In distribution | |
| 9217 | In distribution | ||
| 9004002 | In distribution | ||
| 9014 | In distribution | ||
| 9190 | In distribution | ||
| 9047 | In distribution | ||
| WW3398NC | In distribution | ||
| 1101A | 10 | In distribution | |
| 1121 | 10 | In distribution | |
| 1153B | 25 | In distribution | |
| 1187 | In distribution | ||
| WW1129 | 10 | In distribution | |
| 9212S | 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 |
| 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 |
| Nonin | Nonin Medical, Inc. | 20 |
Showing 12 of 441. All products under Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-14 | Class II | Process control | Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in | 175,994 US; 45,223 OUS | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-14 | Class II | Process control | Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in | 175,994 US; 45,223 OUS | |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-11-29 | Class II | Software design | Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature). | 10 devices | 2018-07-11 |
| Smiths Medical Asd, Inc. | 510(k) number | 2015-03-21 | Class II | Nonconforming Material/Component | The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system. | 5 UPDATE 4-20-2015 to include 10 additional devices | 2015-11-20 |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-02-06 | Class I | Nonconforming Material/Component | In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems. | 39 | 2013-07-12 |
| 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 |
| 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 |
| Smiths Medical Pm, Inc. | 510(k) number | 2008-12-22 | Not classified | Device Design | Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, re | 143 monitors (17 US, 126 OUS) | 2011-12-17 |
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.