Home GUDID B00939251 OCS Lung System
Primary DI B00939251
Brand OCS Lung System
Company TRANSMEDICS, INC.
Model 2464
Catalog number 2464
Device description OCS Lung Monitoring Gas Regulator Kit
Published 2018-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QBA Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QBA Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B00939313 Package HIBCC 1 In Commercial Distribution B00939251 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Donor-organ preservation/transport system gas cylinder regulator A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a donor-organ preservation/transport system gas cylinder to lower high, variable gas to a lower, constant working pressure. The regulated gas is typically a custom mix of oxygen, carbon dioxide and nitrogen used for preservation and/or evaluation of the extracorporeal organ.
Device Sizes# Type, Value, Unit table Type Value Unit Height 3 Inch Length 10 Inch Width 12 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 -20 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 084445043 Device count 1 Serial number true Manufacturing date on label true 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 B00925731 Organ Care System TRANSMEDICS, INC. QBA 2018-06-12 B00925733 Organ Care System TRANSMEDICS, INC. QBA 2018-06-12 B00912500 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00913320 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00914051 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00925681 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00928590 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00928600 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00937641 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939111 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939170 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939180 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939240 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939270 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00940001 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00944670 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00950840 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00953983 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00912501 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00925711 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00954033 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00954003 Organ Care System TRANSMEDICS, INC. QBA 2018-06-01 B00928593 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00928603 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00937663 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00938535 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00937673 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939173 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939183 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939231 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01
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