| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003152463 | 3003152463 | TRANSMEDICS, INC. | 1 | N | 2026-01-01 | 200 MINUTEMAN RD STE 302 Andover MA US 01810 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B00912500 | Organ Care System - OCS Battery | 9785520900 | xx@xx.xx |
| B00944603 | Solution Delivery Cassettes - 1467 | 978-552-0900 | xx@xx.xx |
| B00944670 | OCS Lung System - OCS Lung Solution | 9785520900 | xx@xx.xx |
| B00950770 | OCS Liver System - OCS Liver Bile Salts Set | 978-552-0900 | xx@xx.xx |
| B00950840 | Organ Care System - OCS Battery | 9785520900 | xx@xx.xx |
| B00958753 | OCS Lung Donor Flush Set - 2406 | 9784947494 | xzhuang@transmedics.com |
| B00958755 | OCS Lung Donor Flush Set - 2406 | 9784947494 | xzhuang@transmedics.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 163967 | 1360137588 | P200031 | Organ Care System (OCS™) Liver | QQK | 2021-09-28 |
| 163967 | 1996159695 | P180051 | Organ Care System (OCS) Heart System | QIK | 2021-09-03 |
| 163967 | 1454657405 | P160013 | Organ Care System (OCS™) Lung System | QBA | 2018-03-22 |
| 163967 | 1960535566 | K231362 | OCS Heart Leukocyte Depleting Filter | DTM | 2023-10-31 |
| 163967 | 2009623388 | K222535 | OCS Lung Donor Flush Set | MSB | 2022-11-18 |
| 163967 | 1423000631 | K211314 | OCS Lung Solution | MSB | 2021-07-29 |
| 163967 | 1689164891 |
TransMedics, Inc.200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP200031 Supplement NumberS001 Date Received04/08/2022 Decision Date09/19/2022 Product Code QQK Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02522871 Supplement Typenor...
TransMedics, Inc200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP160013 Supplement NumberS009 Date Received02/07/2022 Decision Date05/06/2022 Product Codes PHO QBA Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Suppleme...
TransMedics, Inc.200 Minuteman Road, Suite 302andover, MA 01810 PMA NumberP180051 Supplement NumberS001 Date Received11/08/2021 Decision Date04/27/2022 Product Code QIK Advisory Committee Cardiovascular Clinical TrialsNCT03831048 Supplement Typepanel Track...
TransMedics, Inc.
TransMedics, Inc.
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TransMedics, Inc
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TransMedics, Inc.
TransMedics, Inc.
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transmedics.com
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