Sarns™ Modular Perfusion System 8000 16413

GUDID 00886799000205

8000 Perfusion System Arterial Monitor Providing Temperature and Pressure Measurement Display.

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system temperature control unit

• Primary Device ID: 00886799000205
• NIH Device Record Key: 6187842a-cc60-4ad8-bb6f-21b4e7c52a5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Modular Perfusion System 8000
• Version Model Number: 16413
• Catalog Number: 16413
• Company DUNS: 177655466
• Company Name: Terumo Cardiovascular Systems Corporation
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886799000205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915183

FDA Product Code

• DTQ: Console, Heart-Lung Machine, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Sarns™ Modular Perfusion System 8000]

• 00886799001776: Base, for Sarns™ Modular Perfusion System 8000
• 00886799001721: Lamp Long 33"
• 00886799000342: Flow meter
• 00886799000236: Line Occluder
• 00886799000229: CDI 500 Comm module for TCVS Sarns 8000
• 00886799000212: Cardioplegia Monitor
• 00886799000205: 8000 Perfusion System Arterial Monitor Providing Temperature and Pressure Measurement Display.
• 00886799000199: 8000 Perfusion System Safety Monitor Providing Air Bubble and Fluid Level Detection Display.
• 00886799000182: Roller Pump, 115V, System 8000
• 00886799000175: Base, for Sarns™ Modular Perfusion System 8000
• 00886799001554: Instrument Tray 8000/9000, Reconditioned
• 00886799000250: Sarns™ Extension arm