Spacelabs Healthcare
Datum+ 5% ENF Selectatec Standard Fill - Chirana
1manufacturer
107catalogue numbers in this listing
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 | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | CAD |
| Device type | Vaporizer, Anesthesia, Non-Heated |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5880 |
| 510(k) | K942799 |
| Record published | 2016-12-29 |
| Record revised | 2019-07-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Storage environment humidity 0 to 0 % RH; Storage environment temperature -20 to 50 °C |
| Distribution end date | 2025-04-04 |
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Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Vapor 3000 | Drägerwerk AG & Co. KGaA | 1 |
Showing 12 of 20. All products under Vaporizer, Anesthesia, Non-Heated
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.