OCS Lung System 2402

GUDID B00943281

OCS Lung Perfusion Initiation Set

TRANSMEDICS, INC.

Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set Donor-organ preservation/transport perfusion initiation/termination set

• Primary Device ID: B00943281
• NIH Device Record Key: 984a57cb-5765-4c36-9b72-dd9ff7c7c228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCS Lung System
• Version Model Number: 2402
• Catalog Number: 2402
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx
• Phone: 9785520900
• Email: xx@xx.xx

Device Dimensions

• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 Inch
• Height: 4 Inch
• Width: 12 Inch
• Length: 18 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	B00937703 [Package]; Package: Cardboard Box [1 Units]; In Commercial Distribution
HIBCC	B00943281 [Primary]

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