Meter, Peak Flow, Spirometry
Pocket Peak - standard range. 1230-0 part number taken out of commercial distribution Correct part number 1230 DID is 00607411001253, already in system.
6manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Salter Labs, United States |
|---|---|
| FDA product code | BZH |
| Device type | Meter, Peak Flow, Spirometry |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1860 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K952713 |
| Record published | 2016-09-24 |
| Record revised | 2020-05-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -40 to 60 °C; Handling environment temperature 5 to 40 °C |
| Distribution end date | 2018-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1236-0-12 | In distribution | |
| 1235-0-12 | In distribution | |
| 1230-0 | Withdrawn |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 |
| 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 |
| Clean Peak Flow Meter | eResearchTechnology 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.