Regulatory & Patents

Regulatory

The OCS Lung, OCS Heart and OCS Liver are all CE marked devices.

The OCS Lung is an FDA-approved device for utilized donor lungs and is under FDA review for use with unutilized donor lungs. The OCS Heart and OCS Liver devices are investigational devices and, are therefore, limited by federal law to investigational use in the US.

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Instructions For Use: OCS Lung

Patents

The following is a list of the TransMedics™ Organ Care System™ (OCS™) patents.

Organ Care System (OCS) Lung
  • U.S. Pat. No. 6,100,082
  • U.S. Pat. No. 6,046,046
  • U.S. Pat. No. 8,585,380
  • U.S. Pat. No. 9,055,740
  • U.S. Pat. No. 8,535,934
  • U.S. Pat. No. 8,420,380
  • U.S. Pat. No. 8,822,203
  • U.S. Pat. No 9,247,728
  • New Zealand Pat. No. 586901
  • New Zealand Pat. No. 600702
  • New Zealand Pat. No. 603329
  • New Zealand Pat. No. 623220
  • Australian Pat. No. 728233
  • Japanese Pat. No. 5599322
  • Japanese Pat. No. 5746534
  • Japanese Pat. No. 5889861
  • Australian Pat. No. 2008260409
  • Australian Pat. No. 2009212725
  • Australian Pat. No. 2013216566
  • Australian Pat. No. 2014256394
  • Chinese Pat. No. ZL200980110231.5
  • Chinese Pat. No. 201310148246.9
  • Chinese Pat. No. ZL201310556156.3
Organ Care System (OCS) Heart
  • U.S. Pat. No. 7,651,835
  • U.S. Pat. No. 6,100,082
  • U.S. Pat. No. 6,046,046
  • U.S. Pat. No. 7,572,622
  • U.S. Pat. No. 8,304,181
  • U.S. Pat. No. 8,409,846
  • U.S. Pat. No. 8,585,380
  • U.S. Pat. No. 8,465,970
  • U.S. Pat. No. 9,055,740
  • U.S. Pat. No. 9,215,867
  • U.S. Pat. No. 9,301,519
  • Israeli Pat. No. 182403
  • Israeli Pat. No. 211084
  • New Zealand Pat. No. 554543
  • New Zealand Pat. No. 580648
  • New Zealand Pat. No. 591524
  • New Zealand Pat. No. 597482
  • New Zealand Pat. No. 600702
  • New Zealand Pat. No. 608461
  • New Zealand Pat. No. 614472
  • New Zealand Pat. No. 625575
  • Australian Pat. No. 728233
  • Hong Kong Pat. No. 1101890
  • Hong Kong Pat. No. 1145942
  • Hong Kong Pat. No. 1185516
  • Belgian Pat. No. 1768490
  • Danish Pat. No. 1768490
  • European Pat. No. 1768490
  • French Pat. No. 1768490
  • German Pat. No. 1768490
  • Irish Pat. No. 1768490
  • Italian Pat. No. 1768490
  • Netherlands Pat. No. 1768490
  • Spanish Pat. No. 1768490
  • Swedish Pat. No. 1768490
  • U.K. Pat. No. 1768490
  • Japanese Pat. No. 5113522
  • Japanese Pat. No. 5462406
  • Japanese Pat. No. 5746534
  • Japanese Pat. No. 5889861
  • Japanese Pat. No. 5933666
  • Australian Pat. No. 2005294206
  • Australian Pat. No. 2008260409
  • Australian Pat. No. 2012216796
  • Australian Pat. No. 2013216566
  • Australian Pat. No. 2014256394
  • Chinese Pat. No. ZL200580042038.4
  • Chinese Pat. No. ZL200880020749.5
  • Chinese Pat. No. ZL201210449227.5
  • Chinese Pat. No. ZL201310556156.3
Organ Care System (OCS) Liver
  • U.S. Pat. No. 6,100,082
  • U.S. Pat. No. 6,046,046
  • U.S. Pat. No. 8,585,380
  • U.S. Pat. No. 9,055,740
  • New Zealand Pat. No. 600702
  • Australian Pat. No. 728233
  • Japanese Pat. No. 5746534
  • Japanese Pat. No. 5889861
  • Australian Pat. No. 2008260409
  • Australian Pat. No. 2013216566
  • Australian Pat. No. 2014256394
  • Chinese Pat. No. ZL201310556156.3
OCS Lung Solution Set
  • U.S. Pat. No. 6,953,655
  • U.S. Pat. No. 9,078,428
  • New Zealand Pat. No. 616699
  • Austrian Pat. No. 1017274
  • Belgian Pat. No. 1017274
  • Danish Pat. No. 1017274
  • European Pat. No. 1017274
  • Finnish Pat. No. 1017274
  • French Pat. No. 1017274
  • German Pat. No. 1017274
  • Irish Pat. No. 1017274
  • Italian Pat. No. 1017274
  • Luxembourg Pat. No. 1017274
  • Monaco Pat. No. 1017274
  • Netherlands Pat. No. 1017274
  • Portuguese Pat. No. 1017274
  • Spanish Pat. No. 1017274
  • Swedish Pat. No. 1017274
  • Swiss Pat. No. 1017274
  • U.K. Pat. No. 1017274
  • Canadian Pat. No. 2304598
  • Japanese Pat. No. 5923551
  • Japanese Pat. No. 5923552
OCS Heart Solution Set
  • U.S. Pat. No. 6,953,655
  • U.S. Pat. No. 9,078,428
  • Austrian Pat. No. 1017274
  • Belgian Pat. No. 1017274
  • Danish Pat. No. 1017274
  • European Pat. No. 1017274
  • Finnish Pat. No. 1017274
  • French Pat. No. 1017274
  • German Pat. No. 1017274
  • Irish Pat. No. 1017274
  • Italian Pat. No. 1017274
  • Luxembourg Pat. No. 1017274
  • Monaco Pat. No. 1017274
  • Netherlands Pat. No. 1017274
  • Portuguese Pat. No. 1017274
  • Spanish Pat. No. 1017274
  • Swedish Pat. No. 1017274
  • Swiss Pat. No. 1017274
  • U.K. Pat. No. 1017274
  • Canadian Pat. No. 2304598
  • Japanese Pat. No. 5923551
  • Japanese Pat. No. 5923552
OCS Liver Sterile Bile Salts Set
  • U.S. Pat. No. 6,953,655
  • U.S. Pat. No. 9,078,428
  • Austrian Pat. No. 1017274
  • Belgian Pat. No. 1017274
  • Danish Pat. No. 1017274
  • European Pat. No. 1017274
  • Finnish Pat. No. 1017274
  • French Pat. No. 1017274
  • German Pat. No. 1017274
  • Irish Pat. No. 1017274
  • Italian Pat. No. 1017274
  • Luxembourg Pat. No. 1017274
  • Monaco Pat. No. 1017274
  • Netherlands Pat. No. 1017274
  • Portuguese Pat. No. 1017274
  • Spanish Pat. No. 1017274
  • Swedish Pat. No. 1017274
  • Swiss Pat. No. 1017274
  • U.K. Pat. No. 1017274
  • Canadian Pat. No. 2304598
  • Japanese Pat. No. 5923551
  • Japanese Pat. No. 5923552

This page is intended to serve as notice under 35 U.S.C. 287(a).