OCS Lung System 2402

GUDID B00943281

OCS Lung Perfusion Initiation Set

TRANSMEDICS, INC.

Donor-organ preservation/transport perfusion initiation/termination set
Primary Device IDB00943281
NIH Device Record Key984a57cb-5765-4c36-9b72-dd9ff7c7c228
Commercial Distribution StatusIn Commercial Distribution
Brand NameOCS Lung System
Version Model Number2402
Catalog Number2402
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx
Phone9785520900
Emailxx@xx.xx

Device Dimensions

Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch
Height4 Inch
Width12 Inch
Length18 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB00937703 [Package]
Package: Cardboard Box [1 Units]
In Commercial Distribution
HIBCCB00943281 [Primary]

FDA Product Code

QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs 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 Date2018-07-02
Device Publish Date2018-06-01

On-Brand Devices [OCS Lung System]

B00944671OCS Lung Solution
B00943281OCS Lung Perfusion Initiation Set
B00940013OCS Lung Manual Inflation Set
B00939313OCS Lung Monitoring Gas Regulator Kit
B00939231OCS Lung Console
B00939183OCS Lung Monitoring Gas Cylinder, Refill
B00939173OCS Lung Monitoring Gas Cylinder
B00937673OCS Lung Instrumentation Tool Set
B00938535OCS Lung Perfusion Set
B00937663OCS Lung Perfusion Termination Set
B00928603OCS Lung Preservation Gas Cylinder, Refill
B00928593OCS Lung Preservation Gas Cylinder

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