D-Vapor
Catalogue number M35500, listed by Drägerwerk AG & Co. KGaA, Germany, under Vaporizer, Anesthesia, Non-Heated. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Drägerwerk AG & Co. KGaA, Germany |
|---|---|
| FDA product code | CAD |
| Device type | Vaporizer, Anesthesia, Non-Heated |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5880 |
| 510(k) | K042276 |
| Record published | 2015-10-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M35500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 107 |
| Penlon | Penlon Ltd. | 11 |
| TEC 7 | Datex-Ohmeda, Inc. | 10 |
| Antispil | Southmedic, Inc. | 5 |
| Vapofil™ | Southmedic, Inc. | 5 |
| TEC | Datex-Ohmeda, Inc. | 4 |
| TEC 6 Plus | Datex-Ohmeda, Inc. | 3 |
| AincA® | Anesthesia Associates, Inc. | 1 |
| Flexible arm assembly FRU | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| V80 Anesthetic Vaporizer | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Sevoflurane Key Filler Vaporizer(FDA) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Key Filler Bottle Adaptor MRI | Penlon Ltd. | 1 |
Showing 12 of 20. All products under Vaporizer, Anesthesia, Non-Heated
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Draeger, Inc. | 510(k) number | 2016-04-21 | Class II | Process change control | Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is rec | 16078 units distributed within the United States | 2016-12-07 |
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.