Sarns™ Infusion Line

GUDID 50699753001942

Terumo Cardiovascular Systems Corporation

Cardioplegia solution administration kit

• Primary Device ID: 50699753001942
• NIH Device Record Key: 90e1afd7-e3a3-4df1-82a2-7d419b92ecd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Infusion Line
• Version Model Number: 16110
• 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	00699753001947 [Primary]
GS1	50699753001942 [Package]; Contains: 00699753001947; Package: 3 Piece Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810079

FDA Product Code

• KRI: Accessory Equipment, Cardiopulmonary Bypass

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: 2015-10-02

On-Brand Devices [Sarns™ Infusion Line]

• 50699753001966: 16130
• 50699753001942: 16110