Sarns™ Modular Perfusion System 8000 16425

GUDID 00886799000250

Sarns™ Extension arm

Terumo Cardiovascular Systems Corporation

Portable active medical device mount Portable active medical device mount Portable active medical device mount Portable active medical device mount Portable active medical device mount Portable active medical device mount Portable active medical device mount Portable active medical device mount Portable active medical device mount Portable active medical device mount Portable active medical device mount

• Primary Device ID: 00886799000250
• NIH Device Record Key: f18e56d4-22ad-4ccf-bc32-88cf96194d36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Modular Perfusion System 8000
• Version Model Number: 16425
• Catalog Number: 16425
• Company DUNS: 177655466
• Company Name: Terumo Cardiovascular Systems Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com
• Phone: 734-822-2564
• Email: patricia.elka@terumomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886799000250 [Primary]

FDA Product Code

• KRI: Accessory Equipment, Cardiopulmonary Bypass

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: 2022-08-08
• Device Publish Date: 2022-07-29

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