CompoSeal Mobilea II
The CompoSeal Mobilea II is intended to be used to seal medical PVC tubing hermetically and create break-off point.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Zhejiang Huawei Scientific Instrument Co Ltd | Linhai | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Fresenius Kabi AB, Sweden |
|---|---|
| FDA product code | GHY |
| Device type | Hematocrit, Tube, Rack, Sealer, Holder |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6400 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Transp. and storage Cond.: Temperature: -20°C – +70°C Rel. Air Hum: 30-75% Air-Pressure: 500-1060 hPa |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9027011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Marketlab Inc | Marketlab Incorporated | 4 |
| Safe-T-Fill® | Ram Scientific | 3 |
| LW Scientific, Inc. | LW Scientific, Inc. | 2 |
| Globe Scientific | Globe Scientific, LLC | 1 |
| Sealing Putty for hematocrit capillaries | Andreas Hettich Gmbh | 1 |
| 75mm Plastic-crit Plain | Drummond Scientific Co. | 1 |
| Hematocrit capillaries | Andreas Hettich Gmbh | 1 |
| 75mm Hemato-clad Heparinized | Drummond Scientific Co. | 1 |
| 75mm Plastic-crit Heparinized | Drummond Scientific Co. | 1 |
| 75mm Self-Sealing Capillary Tubes | Drummond Scientific Co. | 1 |
| 75mm Hemato-clad Plain | Drummond Scientific Co. | 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.