Home GUDID B00925711 Organ Care System
Primary DI B00925711
Brand Organ Care System
Company TRANSMEDICS, INC.
Model 1411
Catalog number 1411
Device description OCS Mobile Base
Published 2018-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 B00925711 Package HIBCC 1 In Commercial Distribution B00913320 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Utility trolley A cart designed for transporting/supplying general-purpose goods, devices, medical equipment, or supplies within a hospital/institution department or ward. This trolley (cart) may have one or more open platforms and may have a handle(s) for pushing the trolley.
Device Sizes# Type, Value, Unit table Type Value Unit Height 10 Inch Length 21 Inch Width 28 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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false 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 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 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 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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