Home GUDID B00949381 OCS Liver System
Primary DI B00949381
Brand OCS Liver System
Company TRANSMEDICS, INC.
Model 3440
Catalog number 3440
Device description OCS Liver Bile Salts Set
Published 2021-12-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 B00949381 Package HIBCC 2 In Commercial Distribution B00950770 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Donor-organ preservation solution additive A sterile powder, containing specifically formulated chemicals, intended to be dissolved in a donor-organ preservation solution to supplement the preservative function of the solution; it may have organ-specific properties to help maintain the viability of the donor organ. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Height 4 Inch Length 4 Inch Width 4 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 084445043 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B00962623 OCS HEART LEUKOCYTE DEPLETING FILTER 1466 1466 2026-05-04 B00958753 OCS Lung Donor Flush Set 2406 2406 2023-06-13 B00958755 OCS Lung Donor Flush Set 2406 2406 2023-06-13 B00912500 Organ Care System 1408 1408 2018-06-01 B00950840 Organ Care System 1408 1408 2018-06-01 B00944670 OCS Lung System 2300 2300 2018-06-01 B00950770 OCS Liver System 3440 3440 2021-12-01 B00926340 OCS Heart System 1300 1300 2021-12-01 B00953973 Organ Care System 1404 1404 2021-12-01 B00953983 Organ Care System 1404 1404 2018-06-01 B00944705 OCS Liver System 3200 3200 2021-12-01 B00944823 OCS Liver System 3400 3400 2021-12-01 B00944833 OCS Liver System 3401 3401 2021-12-01 B00944843 OCS Liver System 3421 3421 2021-12-01 B00946640 OCS Liver System 3406 3406 2021-12-01 B00946650 OCS Liver System 3406 3406 2021-12-01 B00948883 OCS Liver System 3457 3457 2021-12-01 B00950421 OCS Liver System 3450 3450 2021-12-01 B00950480 OCS Liver System 3000 3000 2021-12-01 B00913390 OCS Heart System 1410 1410 2021-12-01
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 05060462240029 OrganOx metra ORGANOX LIMITED QQK 2023-02-20 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
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