ORGANOX LIMITED

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• OrganOx metra System

  2022-07-07

  OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS003 Date Received06/07/2022 Decision Date07/07/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Supplement Typenorm...

• OrganOx metra® System

  2022-05-27

  OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS002 Date Received03/21/2022 Decision Date05/27/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Supplement Typenorm...

• OrganOx metra® System

  2022-04-12

  OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS001 Date Received03/15/2022 Decision Date04/12/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Supplement Typenorm...

• OrganOx metra System

  2021-12-09

  OrganOx Limited

GUDID#

• metra Liver Perfusion Circuit Pack - The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.

  ORGANOX LIMITED

  2022-06-15

• OrganOx metra - The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.

  ORGANOX LIMITED

  2023-02-20

• OrganOx metra - The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.

  ORGANOX LIMITED

  2022-06-15