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 standard and expanded* criteria 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.

 

*Expanded criteria is defined as donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation.

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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).

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