Clean Peak Flow Meter
The Clean Peak Flow Meter is an invasive, non-electrical medical device for monitoring respiratory conditions. The device is for measuring the Peak Expiratory Flow (PEF) or the maximum…
The Clean Peak Flow Meter is an invasive, non-electrical medical device for monitoring respiratory conditions. The device is for measuring the Peak Expiratory Flow (PEF) or the maximum velocity of air expelled from the lungs. The children model is intended for patients from 6 years on up to 12 years.
Who Else Makes It
Concentrated in Guangdong (4), Chongqing (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Shenzhen BI-Rich Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Guangzhou Homesun Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
| Taian Dalu Medical Instrument Co., Ltd. | Taian | Shandong | Contract manufacturer | 2 |
Record
| Listed by | eResearchTechnology GmbH, Germany |
|---|---|
| FDA product code | BZH |
| Device type | Meter, Peak Flow, Spirometry |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1860 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K091412 |
| Record published | 2017-03-01 |
| Record revised | 2021-12-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | serial number |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Clean Peak Flow Meter – Adults | Adult scale: 50 – 800 liters/minutes | Withdrawn |
| Clean Peak Flow Meter – Children | Children scale: 50 – 380 liters/minutes | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mini Wright | Clement Clarke Intl., Ltd. | 12 |
| Personal Best | Respironics Respiratory Drug Delivery (Uk), Ltd. | 10 |
| In-Check | Clement Clarke Intl., Ltd. | 8 |
| PFM | Vitalograph Ireland Ltd. | 7 |
| SpiroFlow | Spirometrics, Inc. | 4 |
| Meter, Peak Flow, Spirometry | Salter Labs | 3 |
| Airzone | Clement Clarke Intl., Ltd. | 3 |
| AincA® | Anesthesia Associates, Inc. | 3 |
| Meter, Peak Flow, Spirometry | Galemed Corp. | 3 |
| Curaplex | TRI-Anim Health Services, Inc. | 3 |
| Asthma Check | Respironics Respiratory Drug Delivery (Uk), Ltd. | 3 |
| Vyaire | Jaeger Medical GmbH | 2 |
Showing 12 of 53. All products under Meter, Peak Flow, Spirometry
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.