Flow Sensor
Flow sensor SpiroQuant A+
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
Record
| Listed by | Honeywell Healthcare Solutions GmbH |
|---|---|
| FDA product code | BXP |
| Device type | Transducer, Gas Flow |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2885 |
| Premarket notification | Exempt |
| Record published | 2016-09-22 |
| Record revised | 2024-08-01 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment temperature 15 to 40 °C; Storage environment temperature -20 to 70 °C |
| Sizes | Height 40 mm; length 110 mm; width 140 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SpiroQuant A+ | Height 40 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flow Sensor | Respironics Novametrix, LLC | 10 |
| Create Biotech | Create Biotech Co., Ltd. | 8 |
| Puritan Bennett | Covidien LP | 2 |
| Infinity ID Flow Sensor | Drägerwerk AG & Co. KGaA | 1 |
| Respiratory Mech mod,w/accssry | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Respiratory Mechanics Flow Sensor → Adult/Pediatric | Draeger Medical Systems, Inc. | 1 |
| Spirolog Flow Sensor | Drägerwerk AG & Co. KGaA | 1 |
| SpiroLife | Drägerwerk AG & Co. KGaA | 1 |
| Spiro-SP TrueFlow Sensor | NDD Medizintechnik AG | 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.