Andorate® 4-Piece Valve Kit
Catalogue number GAR046, listed by GA Health Company Limited, Hong Kong, under Autonomous Extracorporeal Blood Leak Detector/Alarm. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Tianjin. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
Record
| Listed by | GA Health Company Limited, Hong Kong |
|---|---|
| FDA product code | ODX |
| Device type | Autonomous Extracorporeal Blood Leak Detector/Alarm |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-05-28 |
| Record revised | 2022-01-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 50, carton of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GAR046 | In distribution |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GA Health Company Limited | UDI-DI | 2020-11-03 | Class II | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | 93,700 units | 2021-09-03 |
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.