OCS Lung Donor Flush Set
Catalogue number 2406, listed by Transmedics, Inc., United States, under System And Accessories, Isolated Heart, Transport And Preservation. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Registered in Fujian. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
Record
| Listed by | Transmedics, Inc., United States |
|---|---|
| FDA product code | MSB |
| Device type | System And Accessories, Isolated Heart, Transport And Preservation |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5880 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2023-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature -20 to 50 °C; Handling environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Cardboard box |
| Sizes | Height 4 in; width 12 in; length 18 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2406 | Height 4 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies, Inc. | 8 |
| Custodiol | Dr. Franz Köhler Chemie GmbH | 2 |
| Servator H | Global Transplant Solutions, Inc. | 1 |
| Servator C Salf Solution | S.a.l.f. SPA Laboratorio Farmacologico | 1 |
| SherpaPak Cardiac Transport System (CTS) | Paragonix Technologies, Inc. | 1 |
| Celsior Cold Storage Solution | Institut Georges Lopez | 1 |
| Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222535 | 2022-11-18 |
| K211314 | 2021-07-29 |
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.