Organ Care System 1404

GUDID B00953985

OCS Data Card

TRANSMEDICS, INC.

Data storage card

• Primary Device ID: B00953985
• NIH Device Record Key: b9c7d2ba-25b5-409f-af93-a4698db29e22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Organ Care System
• Version Model Number: 1404
• Catalog Number: 1404
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Dimensions

• Height: 0.08 Inch
• Width: 1.25 Inch
• Length: 1 Inch
• Height: 0.08 Inch
• Width: 1.25 Inch
• Length: 1 Inch
• Height: 0.08 Inch
• Width: 1.25 Inch
• Length: 1 Inch
• Height: 0.08 Inch
• Width: 1.25 Inch
• Length: 1 Inch
• Height: 0.08 Inch
• Width: 1.25 Inch
• Length: 1 Inch
• Height: 0.08 Inch
• Width: 1.25 Inch
• Length: 1 Inch
• Height: 0.08 Inch
• Width: 1.25 Inch
• Length: 1 Inch
• Height: 0.08 Inch
• Width: 1.25 Inch
• Length: 1 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B00953983 [Primary]
HIBCC	B00953985 [Package]; Contains: B00953983; 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: false

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 [Organ Care System]

• B00953985: OCS Data Card
• B00950841: OCS Battery
• B00939301: OCS Wireless Monitor, Universal
• B00925733: Pump Flow Probe
• B00954003: OCS Regulator Yoke Gasket
• B00954033: OCS Power Cord, North America
• B00925711: OCS Mobile Base
• B00912501: OCS Battery
• B00953975: OCS Data Card