Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
B40V3 ATO Generic Model
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 Medical Systems Information Technologies, Inc., United States |
|---|---|
| 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 |
| Record published | 2016-06-15 |
| Record revised | 2025-04-16 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 20 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C; Handling environment temperature 5 to 35 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B40 Patient Monitor | Withdrawn |
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 |
| Waveline EZ-MAX | Avante | 1 |
| Carescape RAD | GE Healthcare Finland OY | 1 |
| Water Trap | Philips Medizin Systeme Böblingen GmbH | 1 |
Showing 12 of 13. All products under Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
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.