OrganOx metra System
OrganOx Limited
ORGANOX LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011560054 | 3011560054 | ORGANOX LIMITED | 1 | N | 2027-01-01 | 3500 John Smith Drive Oxford Business Park Oxford Oxfordshire GB OX4 2WB |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 304514 | 1948559141 | P200035 | OrganOx metra System | QQK | 2021-12-09 |
| 304514 | 1799840691 | K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | DRY | 2014-07-25 |
Product Codes Associated With Registrations#
PMA#
GUDID#
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.
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.
2022-06-15
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.
2022-06-15