Flow Sensor
Flow sensor SpiroQuant H 3m
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhangjiagang Carenovo Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 9 |
Record
| Listed by | Honeywell Healthcare Solutions GmbH |
|---|---|
| FDA product code | BYR |
| Device type | Transducer, Gas Pressure, Differential |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2875 |
| Premarket notification | Exempt |
| Record published | 2016-09-22 |
| Record revised | 2024-08-01 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 0 to 99 % RH; Storage environment temperature -20 to 70 °C; Handling environment temperature 0 to 50 °C |
| Sizes | Length 155 to 200 mm; width 150 to 210 mm; height 105 to 130 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SpiroQuant H | Height 130 mm | In distribution |
| SpiroQuant H | Height 105 mm | In distribution |
| SpiroQuant H 3m | Length 200 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BluHale PRO™ | Mannkind Corporation | 1 |
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.