Isoflurane Key Filler Vaporizer(FDA)
Catalogue number 115-025535-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Vaporizer, Anesthesia, Non-Heated. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
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 | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | CAD |
| Device type | Vaporizer, Anesthesia, Non-Heated |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5880 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-20 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115-025535-00 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240375 | 2024-10-31 |
| K150167 | 2015-06-30 |
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.