| Primary Device ID | B00939313 |
| NIH Device Record Key | 3250cb73-c5bc-4ee1-b455-4a17fc7d8a55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OCS Lung System |
| Version Model Number | 2464 |
| Catalog Number | 2464 |
| Company DUNS | 084445043 |
| Company Name | TRANSMEDICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9785520900 |
| xx@xx.xx | |
| Phone | 9785520900 |
| xx@xx.xx |
| Height | 3 Inch |
| Width | 12 Inch |
| Length | 10 Inch |
| Height | 3 Inch |
| Width | 12 Inch |
| Length | 10 Inch |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B00939251 [Primary] |
| HIBCC | B00939313 [Package] Contains: B00939251 Package: Cardboard Box [1 Units] In Commercial Distribution |
| QBA | Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-02 |
| Device Publish Date | 2018-06-01 |
| B00944671 | OCS Lung Solution |
| B00943281 | OCS Lung Perfusion Initiation Set |
| B00940013 | OCS Lung Manual Inflation Set |
| B00939313 | OCS Lung Monitoring Gas Regulator Kit |
| B00939231 | OCS Lung Console |
| B00939183 | OCS Lung Monitoring Gas Cylinder, Refill |
| B00939173 | OCS Lung Monitoring Gas Cylinder |
| B00937673 | OCS Lung Instrumentation Tool Set |
| B00938535 | OCS Lung Perfusion Set |
| B00937663 | OCS Lung Perfusion Termination Set |
| B00928603 | OCS Lung Preservation Gas Cylinder, Refill |
| B00928593 | OCS Lung Preservation Gas Cylinder |