Product code QBA
- Device name
- Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To preserve donor lungs prior to transplantation
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P160013S021 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2026-05-13 |
| P160013S020 | Organ Care System™ (OCS™) Lung System | TransMedics, Inc. | 2025-12-16 |
| P160013S019 | Organ Care System™ (OCS™) Lung System | TransMedics, Inc. | 2025-10-22 |
| P160013S018 | Organ Care System™ (OCS™) Lung | TransMedics, Inc. | 2024-10-11 |
| P160013S016 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2024-01-09 |
| P160013S014 | Organ Care System™ (OCS™) Lung | TransMedics, Inc. | 2023-06-28 |
| P160013S013 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2023-06-28 |
| P160013S012 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2023-05-09 |
| P160013S010 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2023-02-24 |
| P160013S011 | Organ Care System (OCS™) Lung | TransMedics, Inc. | 2023-02-23 |
| P160013S009 | Organ Care System™ (OCS) Lung System | TransMedics, Inc. | 2022-05-06 |
| P160013S008 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2021-08-02 |
| P160013S007 | Organ Care System (OCS) Lung System | TransMedics, Inc. | 2020-12-03 |
| P160013S006 | Organ Care System (OCS) Lung System | TransMedics, Inc. | 2019-12-20 |
| P160013S005 | Organ Care System (OCS) Lung System | TransMedics, Inc. | 2019-12-20 |
| P160013S002 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2019-05-31 |
| P160013S003 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2018-12-21 |
| P160013S001 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2018-06-14 |
| P160013 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | 2018-03-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B00925731 | Organ Care System | TRANSMEDICS, INC. | 2018-06-12 |
| B00925733 | Organ Care System | TRANSMEDICS, INC. | 2018-06-12 |
| B00944670 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00939183 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00939173 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00937673 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00938535 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00937663 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00928603 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00928593 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00954003 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00954033 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00925711 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00912501 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00953983 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00950840 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00912500 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00940001 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00939270 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00939251 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00939240 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00939180 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00939170 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00939111 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00937641 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00928600 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00928590 | OCS Lung System | TRANSMEDICS, INC. | 2018-06-01 |
| B00925681 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00914051 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |
| B00913320 | Organ Care System | TRANSMEDICS, INC. | 2018-06-01 |