Vmax
SWR KIT, Data Convert - Vmax TO SQL
1manufacturer
27catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Homesun Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | Vyaire Medical, Inc., United States |
|---|---|
| FDA product code | BTY |
| Device type | Calculator, Predicted Values, Pulmonary Function |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1890 |
| 510(k) | K942211 |
| Record published | 2021-04-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 18 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 773799 | In distribution | |
| 777410-103 | In distribution | |
| 28282-001 | In distribution | |
| 777400-103 | In distribution | |
| 777400-101 | In distribution | |
| 777543-101 | In distribution | |
| 29122-507 | In distribution | |
| 30923-607 | In distribution | |
| 28278-001 | In distribution | |
| 28281-001 | In distribution | |
| 001-375119 | In distribution | |
| 673666 | In distribution | |
| 30923-507 | In distribution | |
| 777408-101 | In distribution | |
| 775540-101 | In distribution | |
| 92116 | In distribution | |
| 776268-103 | In distribution | |
| 777417 | In distribution | |
| 777425 | In distribution | |
| 92650-102 | In distribution | |
| 63811 | In distribution | |
| 777404-101 | In distribution | |
| 777409-101 | In distribution | |
| 777407-103 | In distribution | |
| 777416 | In distribution | |
| 777407-101 | In distribution | |
| 776269 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vmax | Carefusion | 59 |
| Jaeger | Jaeger Medical GmbH | 16 |
| SpiroSphere | eResearchTechnology GmbH | 15 |
| Vyaire | Jaeger Medical GmbH | 8 |
| Cosmed | C O S M E D SRL | 8 |
| MasterScope | eResearchTechnology GmbH | 7 |
| Shape-HF | Shape Medical Systems, Inc | 3 |
| Avea | Vyaire Medical, Inc. | 3 |
| Pneumotach | eResearchTechnology GmbH | 2 |
| ERT PT | eResearchTechnology GmbH | 2 |
| Shape | Shape Medical Systems, Inc | 2 |
| MasterScreen | Jaeger Medical GmbH | 2 |
Showing 12 of 28. All products under Calculator, Predicted Values, Pulmonary Function
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.