Aerosizer®
2 catalogue numbers from 00884450031117, listed by Merit Medical Systems, Inc., United States, under Device, Measuring, For Panendoscope. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | FDY |
| Device type | Device, Measuring, For Panendoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-04 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450031117 | In distribution | |
| D | In distribution |
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.