A7 Multi Gas Module With Accessory Kit
Catalogue number 115-016575-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Gas-Machine, Anesthesia. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
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 | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | BSZ |
| Device type | Gas-Machine, Anesthesia |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5160 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K151954 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115-016575-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A9800 Anesthesia Workstation | Oricare Inc. | 22 |
| 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 |
Showing 12 of 293. All products under Gas-Machine, Anesthesia
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253330 | 2026-06-25 |
| K201957 | 2021-03-26 |
| K171311 | 2018-01-12 |
| K171292 | 2018-01-12 |
| K151954 | 2015-10-27 |
| K142552 | 2015-01-23 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Mindray DS USA, Inc. | 510(k) number | 2017-07-14 | Class II | Device Design | A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test. | 2875 in total | 2019-04-17 |
| Beckman Coulter, Inc. | 510(k) number | 2016-08-04 | Class II | Under Investigation by firm | Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire. | 759 units total (358 units in US) | 2016-10-06 |
| Mindray DS USA, Inc. | 510(k) number | 2016-06-15 | Class II | Nonconforming Material/Component | Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System. | 167 units (165 units – US) and (2 units – International) | 2017-03-28 |
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.