Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
B125 V1 Patient Monitor ATO Model
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), 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 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | NHP |
| Device type | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2017-11-14 |
| Record revised | 2025-04-17 (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 temperature 5 to 35 °C; Storage environment temperature -20 to 60 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B125 Patient Monitor | Withdrawn | |
| B105 Patient Monitor | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | GE Healthcare Finland OY | 2 |
| Carescape | GE Medical Systems Information Technologies, Inc. | 1 |
| Carescape B650 | 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.