Sarns™ Cardioplegia Delivery Line

GUDID 50699753001959

Terumo Cardiovascular Systems Corporation

Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit

• Primary Device ID: 50699753001959
• NIH Device Record Key: bcdb63b1-826d-4323-a65f-a11723c58393
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Cardioplegia Delivery Line
• Version Model Number: 16105
• 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	00699753001954 [Primary]
GS1	50699753001959 [Package]; Contains: 00699753001954; 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

Devices Manufactured by Terumo Cardiovascular Systems Corporation

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• 50699753531227 - Cardiovascular Procedure Kit: 2024-04-19
• 50699753531234 - Cardiovascular Procedure Kit: 2024-04-19
• 50699753531180 - Cardiovascular Procedure Kit: 2024-04-18
• 00699753531192 - Cardiovascular Procedure Kit: 2024-04-18
• 00699753531208 - Cardiovascular Procedure Kit: 2024-04-18
• 50699753531104 - Cardiovascular Procedure Kit: 2024-04-15
• 50699753531111 - Cardiovascular Procedure Kit: 2024-04-15