Home GUDID B00940001 OCS Lung System
Primary DI B00940001
Brand OCS Lung System
Company TRANSMEDICS, INC.
Model 2404
Catalog number 2404
Device description OCS Lung Manual Inflation Set
Published 2018-06-01
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 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 B00940013 Package HIBCC 1 In Commercial Distribution B00940001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Breathing circuit bag, single-use A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Height 4 Inch Length 18 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 Lot or batch true Expiration 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 B00939251 OCS Lung System TRANSMEDICS, INC. QBA 2018-06-01 B00939270 Organ Care 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
xx.xx