Home GUDID B00925741
OCS Heart System
Primary DI B00925741
Brand OCS Heart System
Company TRANSMEDICS, INC.
Model 1425
Catalog number 1425
Device description Coronary Flow Probe
Published 2021-12-01
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 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 B00925743 Package HIBCC 1 In Commercial Distribution B00925741 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Extracorporeal fluid flow probe An electronic device intended to be used to measure rate of fluid flow in an extracorporeal perfusion system tube using ultrasound transit time technology. It typically clamps over the exterior of a flexible tube and is used in conjunction with a flowmeter/flowmeter board incorporated into the perfusion system. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Height 2.3 Inch Length 9 Inch Width 5.13 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 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 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 B00925751 OCS Heart System TRANSMEDICS, INC. QIK 2021-12-01 B00926340 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