Carescape RAD
Catalogue number MBRA001, listed by GE Healthcare Finland OY, Finland, under Analyzer, Gas, Halothane, 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 | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | CBS |
| Device type | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1620 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213363 |
| Record published | 2020-03-05 |
| Record revised | 2024-10-11 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MBRA001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Philips Medizin Systeme Böblingen GmbH | 3 |
| Irma™ AX+ | Masimo Corporation | 3 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | GE Healthcare Finland OY | 2 |
| Waveline Pro+ | Avante | 2 |
| Irma Airway Adapter | Masimo Corporation | 2 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 1 |
| Carescape Canvas D19 | GE Healthcare Finland OY | 1 |
| IntelliVue G7m Gas Analyzer Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Waveline Touch+ | Avante | 1 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | GE Medical Systems Information Technologies, Inc. | 1 |
| Waveline EZ-MAX | Avante | 1 |
| Water Trap | Philips Medizin Systeme Böblingen GmbH | 1 |
Showing 12 of 13. All products under Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
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 |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 3271 |
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.