Home GUDID 05060462240029 OrganOx metra
Primary DI 05060462240029
Brand OrganOx metra
Company ORGANOX LIMITED
Model D0146
Device description 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.
Published 2023-02-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060462240029 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060462240029 05060462240029 5060462240029
GMDN Terms# Term, Definition table Term Definition Liver donor-organ preservation/transport system A dedicated system designed to support and maintain a donated liver organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 211154142 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Contains natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060462240043 metra Liver Perfusion Circuit Pack D0146-US 2022-06-15 05060462240005 OrganOx metra D0003 2022-06-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 16945630123075 Sterilance Soft Lancet 26G Sterilance Medical (Suzhou) Inc. QQK 2024-01-15 36945630123079 Sterilance Soft Lancet 26G Sterilance Medical (Suzhou) Inc. QQK 2024-01-15 05060462240005 OrganOx metra ORGANOX LIMITED QQK 2022-06-15 05060462240043 metra Liver Perfusion Circuit Pack ORGANOX LIMITED QQK 2022-06-15 B00944705 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00944823 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00944833 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00944843 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00946640 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00946650 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00948883 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00950421 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00950480 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00950770 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00944707 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00944895 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00944905 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00944915 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00946643 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00946653 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00948895 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00950443 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00950491 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01 B00949381 OCS Liver System TRANSMEDICS, INC. QQK 2021-12-01