OCS Heart System 1406

GUDID B00913600

OCS Heart Gas Cylinder

TRANSMEDICS, INC.

Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder Donor-organ preservation/transport system gas refillable cylinder

• Primary Device ID: B00913600
• NIH Device Record Key: 25ddca65-3293-4858-b3e9-8d637531833f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCS Heart System
• Version Model Number: 1406
• Catalog Number: 1406
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx
• Phone: 978-552-0900
• Email: xx@xx.xx

Device Dimensions

• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch
• Length: 18 Inch
• Width: 4 Inch
• Height: 4 Inch

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT STORE NEAR HEAT OR AN OPEN FLAME
• Special Storage Condition, Specify: Between 0 and 0 *STORE WITH ADEQUATE VENTILATION

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B00913600 [Primary]
HIBCC	B00913603 [Package]; Package: Cardboard Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180051

FDA Product Code

• QIK: Organ Care System (Ocs) Heart System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-09
• Device Publish Date: 2021-12-01

On-Brand Devices [OCS Heart System]

• B00949290: OCS Heart Console
• B00948913: OCS Heart Solution Line Set
• B00948225: OCS Heart Perfusion Set
• B00943661: Cable Tie Tool, Small Diameter
• B00936463: OCS Cardioplegic Arrest Set
• B00936363: OCS Heart Instrumentation Tool Set
• B00926340: OCS Heart Solution Set
• B00925751: SvO2/HCT Probe
• B00925741: Coronary Flow Probe
• B00925721: Aortic Flow Probe
• B00924420: OCS Heart Gas Cylinder, Refill
• B00918043: OCS Blood Collection Set
• B00913600: OCS Heart Gas Cylinder
• B00913390: OCS Wireless Monitor, Heart