Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
E-SCAIOE-00, Module Assembly
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 Healthcare Finland OY, Finland |
|---|---|
| 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 |
| 510(k) | K051092 |
| Record published | 2016-06-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 66 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment humidity 10 to 98 % RH; Storage environment temperature -25 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D-fend Water Trap, 876446-HEL | In distribution | |
| E-sCAiOE-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | GE Medical Systems Information Technologies, Inc. | 2 |
| Carescape | GE Medical Systems Information Technologies, Inc. | 1 |
| Carescape B650 | GE Healthcare Finland OY | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2015-04-24 | Class II | Nonconforming Material/Component | A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. This water trap occlusion could cause a l | 5,018 (US = 2,948 / OUS = 2,070) | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2014-05-23 | Class II | Nonconforming Material/Component | Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. | 4,961 (1,946 units US, 3,015 units OUS) | 2015-10-21 |
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.