Sarns™ Cardioplegia Set

GUDID 50699753001546

Terumo Cardiovascular Systems Corporation

Cardioplegia solution administration kit

• Primary Device ID: 50699753001546
• NIH Device Record Key: 5c24eef3-a12a-4e38-bf08-106c42ca456f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sarns™ Cardioplegia Set
• Version Model Number: 16015
• 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	00699753001541 [Primary]
GS1	50699753001546 [Package]; Contains: 00699753001541; Package: 4 Piece Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823451

FDA Product Code

• DTR: Heat-Exchanger, 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™ Cardioplegia Set]

• 50699753009085: 5852
• 50699753008538: 6375
• 50699753008521: 6376
• 50699753005476: 4459
• 50699753002949: 9457
• 50699753002000: 16200
• 50699753001546: 16015
• 50699753001539: 16010
• 50699753001386: 15501
• 50699753001362: 15486
• 50699753001218: 14915
• 50699753000273: 165720