Home GUDID B00926340 OCS Heart System
Primary DI B00926340
Brand OCS Heart System
Company TRANSMEDICS, INC.
Model 1300
Catalog number 1300
Device description OCS Heart Solution Set
Published 2021-12-01
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 QIK Organ Care System (Ocs) Heart System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QIK Organ Care System (Ocs) Heart System Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B00926341 Package HIBCC 4 In Commercial Distribution B00926340 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Donor-organ preservation solution A sterile solution intended to be used in conjunction with a donor-organ preservation/transport set for the flushing, transport, storage and preservation of donor organs (e.g., kidney, liver, heart, and pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain organ viability until the organ can be implanted in the recipient; the solution may be combined with blood. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Height 3 Inch Length 20 Inch Width 15 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 10 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature 0 Degrees Celsius 25 Degrees Celsius Special Storage Condition, Specify 0 0 DO NOT EXPOSE TO DIRECT SUNLIGHT Special Storage Condition, Specify 0 0 DO NOT GET WET
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 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 B00913600 OCS Heart System 1406 1406 2021-12-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B00953973 Organ Care System TRANSMEDICS, INC. QIK 2021-12-01 B00913390 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00913600 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00918043 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00924420 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00925721 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00925741 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00925751 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00936363 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00936463 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00943661 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00948225 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00948913 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00949290 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00953975 Organ Care System TRANSMEDICS, INC. QIK 2021-12-01
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