SMR Integrated Mount Accessory Kit
Catalogue number 115-045621-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.). 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | CBR |
| Device type | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1700 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K190011 |
| Record published | 2020-05-06 |
| Record revised | 2021-11-10 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115-045621-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Healthcare Finland OY | 4 |
| Trulink | Spacelabs Healthcare (Washington), Inc | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 1 |
| 19″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 22″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| UltraviewSL | Spacelabs Healthcare (Washington), Inc | 1 |
| AG Module(O2/package/accessory) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 19″display(adapter/10M/VP1) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Medical Systems Information Technologies, Inc. | 1 |
| Spacelabs | Spacelabs Healthcare (Washington), Inc | 1 |
| Carescape B850 | GE Healthcare Finland OY | 1 |
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.