Sarns™ Centrifugal Pump with X-Coating™

GUDID 50699753450320

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 50699753450320
• NIH Device Record Key: 93aa0b53-f45c-41ae-8e47-d66021c852ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Centrifugal Pump with X-Coating™
• Version Model Number: 164275X
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00699753450325 [Primary]
GS1	50699753450320 [Package]; Contains: 00699753450325; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112229

FDA Product Code

• KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [Sarns™ Centrifugal Pump with X-Coating™ ]

• 50699753450344: CV-164275X
• 50699753450320: 164275X