GaleMed
CV-3 Single Limb Manifold
1manufacturer
1catalogue number
Who Else Makes It
Registered in Fujian.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
Record
| Listed by | GaleMed (Xiamen) Co., Ltd., China |
|---|---|
| FDA product code | BXO |
| Device type | Transducer, Gas Pressure |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2900 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-09-19 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 60 °C |
| Packaging | Carton of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 71050 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MedPak | Lifeport, LLC. | 2 |
| FRU, Pressure Transducer, 0-100 PSI | Accutron, Inc. | 1 |
| Transducer, Gas Pressure | AirLife Finland Oy | 1 |
| Transducer, Guardian II Replacement Kit | Accutron, Inc. | 1 |
| FRU, Pressure Transducer, 0-100 PSI, NPT | Accutron, Inc. | 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.