Sarns™ Centrifugal System 6379

GUDID 00886799000076

Centrifugal Pump Speed Control Module

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system centrifugal pump drive unit Cardiopulmonary bypass system centrifugal pump drive unit

• Primary Device ID: 00886799000076
• NIH Device Record Key: 6d352dfc-6fda-428e-9cd8-307f873695ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Centrifugal System
• Version Model Number: 6379
• Catalog Number: 6379
• 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	00886799000076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950739

FDA Product Code

• DWA: Control, Pump Speed, 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™ Centrifugal System]

• 00886799001714: Spare Pump Power Cord for the Centrifugal Pump Back-Up Battery.
• 00886799000120: Centrifugal Pump Back-Up Battery
• 00886799000076: Centrifugal Pump Speed Control Module