OCS Lung System 2200

GUDID B00938535

OCS Lung Perfusion Set

TRANSMEDICS, INC.

Lung donor-organ preservation/transport perfusion set

Primary Device ID	B00938535
NIH Device Record Key	be6562d6-ad1f-4424-91e5-b8720075f6a1
Commercial Distribution Status	In Commercial Distribution
Brand Name	OCS Lung System
Version Model Number	2200
Catalog Number	2200
Company DUNS	084445043
Company Name	TRANSMEDICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch
Height	21 Inch
Width	27 Inch
Length	27 Inch

Operating and Storage Conditions

Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B00938535 [Primary]
HIBCC	B00938537 [Package] Package: Cardboard Box [1 Units] In Commercial Distribution

FDA Product Code

QBA	Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-07-02
Device Publish Date	2018-06-01

On-Brand Devices [OCS Lung System]

B00944671	OCS Lung Solution
B00943281	OCS Lung Perfusion Initiation Set
B00940013	OCS Lung Manual Inflation Set
B00939313	OCS Lung Monitoring Gas Regulator Kit
B00939231	OCS Lung Console
B00939183	OCS Lung Monitoring Gas Cylinder, Refill
B00939173	OCS Lung Monitoring Gas Cylinder
B00937673	OCS Lung Instrumentation Tool Set
B00938535	OCS Lung Perfusion Set
B00937663	OCS Lung Perfusion Termination Set
B00928603	OCS Lung Preservation Gas Cylinder, Refill
B00928593	OCS Lung Preservation Gas Cylinder