A9800 Anesthesia Workstation
The A9800 Anesthesia Workstation provides pneumatically driven, electronically controlled ventilation during anesthesia. Its breathing system includes a bellows, electronically regulated…
The A9800 Anesthesia Workstation provides pneumatically driven, electronically controlled ventilation during anesthesia. Its breathing system includes a bellows, electronically regulated expiratory pressure and controls for manual or automatic ventilation.
Automatic modes include volume control, pressure control, pressure support with apnea backup, synchronized intermittent mandatory ventilation and pressure-controlled ventilation with volume guarantee. An adjustable pressure-limiting valve and breathing bag support manual ventilation.
Listed Item
Anesthesia Workstation with standard features to include: Side Stream Gas. Chinese Language. China Power Setup
Gas Monitoring and Controls
Electronic flowmeters display fresh oxygen, air and nitrous oxide flow. An accessory analyzer monitors oxygen, carbon dioxide, nitrous oxide and anesthetic gases, while a scavenging system removes waste gas. A 15-inch touchscreen and navigator wheel provide controls, waveforms, alarms and spirometry-loop displays.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Prunus Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Oricare Inc., United States |
|---|---|
| FDA product code | BSZ |
| Device type | Gas-Machine, Anesthesia |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5160 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K131790 |
| Record published | 2016-03-25 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 5 to 95 % RH; Storage environment temperature -10 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution | |
| A9800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analgesia GAS Mixer, Digital MDM Delivery System | Parker Hannifin Corp. | 12 |
| Aladin2 | Datex-Ohmeda, Inc. | 12 |
| Penlon | Penlon Ltd. | 7 |
| Analgesia GAS Mixer, MDM Delivery System | Parker Hannifin Corp. | 6 |
| Codonics SLS500i Operating Software | Codonics, Inc. | 4 |
| Codonics Safe Label System®(SLS) 500i Point of Care Station | Codonics, Inc. | 4 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 4 |
| Codonics Safe Label System®(SLS) 550i Point of Care Station – 144C | Codonics, Inc. | 3 |
| Aestiva | Datex-Ohmeda, Inc. | 2 |
| Aisys | Datex-Ohmeda, Inc. | 2 |
| Infinium Medical Inc. | Infinium Medical, Inc. | 2 |
| Aespire | Datex-Ohmeda, Inc. | 2 |
Showing 12 of 293. All products under Gas-Machine, Anesthesia
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131790 | 2014-05-09 |
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.