BCI
35 catalogue numbers from 3304, listed by ICU Medical, Inc, United States, under Oximeter. 70 manufacturers in China are registered for this product code.
70manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (46), Jiangsu (7), Beijing (5). 10 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 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Beijing Kingst Commercial & Trade Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Showing 12 of 70. All 70 manufacturers in China registered for Oximeter
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K070732 |
| Record published | 2016-10-13 |
| Record revised | 2025-04-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 10 |
| Distribution end date | 2019-08-13 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3304 | In distribution | ||
| WW3078 | In distribution | ||
| 3375 | In distribution | ||
| 3304LS | In distribution | ||
| WW3350 | In distribution | ||
| WW1018B | In distribution | ||
| 6120N | In distribution | ||
| 1300 | 10 | In distribution | |
| WW1020A1EN | In distribution | ||
| WW1028SYS | In distribution | ||
| WW1020EN | In distribution | ||
| 3301A2 | In distribution | ||
| WW1025SYS | In distribution | ||
| 3419 | In distribution | ||
| 6120C | In distribution | ||
| WW1096SYS | In distribution | ||
| WW1020P1EN | In distribution | ||
| 6120A | In distribution | ||
| 1301 | In distribution | ||
| 6014 | 1,000 | In distribution | |
| 3178 | In distribution | ||
| WW1030P1EN | In distribution | ||
| WW1000A1EN | In distribution | ||
| 1302 | In distribution | ||
| WW1021SYS | In distribution | ||
| WW1018G | In distribution | ||
| 21-0470-0105-24 | In distribution | ||
| 3301A4 | In distribution | ||
| WW1026SYS | In distribution | ||
| 1303 | In distribution | ||
| 3301A1 | In distribution | ||
| WW1030EN | In distribution | ||
| WW1000EN | In distribution | ||
| 6015R | In distribution | ||
| 21-0469-0105-24 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 2,838 |
| APK | APK Technology Co., Ltd. | 2,678 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 151 |
| Nellcor | Covidien LP | 138 |
| Nonin | Nonin Medical, Inc. | 129 |
| Orantech | Orantech Inc. | 97 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 93 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Medichoice | Owens & Minor Distribution, Inc. | 62 |
| Caremed | Shenzhen Caremed Medical Technology Co., Ltd. | 55 |
| Sensoronics | Sensoronics Incorporated | 53 |
| Virtuox | Healthcare Logistics Systems | 36 |
Showing 12 of 1,063. All products under Oximeter
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 | 2008-04-02 | Not classified | Employee error | Due to a component that may be installed backwards, the device may turn off or may immediately reset. | 195 | 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.