OCS Liver System 3440

GUDID B00949381

OCS Liver Bile Salts Set

TRANSMEDICS, INC.

Donor-organ preservation solution additive
Primary Device IDB00949381
NIH Device Record Key516309b5-477b-4606-9228-8f39310ad007
Commercial Distribution StatusIn Commercial Distribution
Brand NameOCS Liver System
Version Model Number3440
Catalog Number3440
Company DUNS084445043
Company NameTRANSMEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx
Phone978-552-0900
Emailxx@xx.xx

Device Dimensions

Length4 Inch
Width4 Inch
Height4 Inch
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Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB00949381 [Package]
Contains: B00950770
Package: Cardboard Box [2 Units]
In Commercial Distribution
HIBCCB00950770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QQKNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-09
Device Publish Date2021-12-01

On-Brand Devices [OCS Liver System]

B00949381OCS Liver Bile Salts Set
B00950491OCS Liver Console
B00950443Bile Cannula, 12FR
B00948895OCS Liver Solution Infusion Set
B00946653OCS Liver Gas Cylinder, Refill
B00946643OCS Liver Gas Cylinder
B00944915OCS Liver Perfusion Termination Set
B00944905OCS Liver Instrumentation Tool Set
B00944895OCS Liver Perfusion Initiation Set
B00944707OCS Liver Perfusion Set

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