Vapor 2000
Catalogue number M35054, 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) | K971923 |
| Record published | 2015-10-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M35054 | 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
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 |
|---|---|---|---|---|---|---|
| Draeger, Inc. | 510(k) number | 2025-11-24 | Class I | Under Investigation by firm | A certain component of affected devices was not delivered within specification and contained impurities. | 431 units |
| Draeger, Inc. | 510(k) number | 2025-11-24 | Class I | Under Investigation by firm | A certain component of affected devices was not delivered within specification and contained impurities. | 188 units |
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.