s5i Imaging System Workstation

GUDID 00845225012045

VOLCANO CORPORATION

Cardiovascular ultrasound imaging system

• Primary Device ID: 00845225012045
• NIH Device Record Key: 570ba665-ec77-4224-aa07-a1923c422607
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s5i Imaging System Workstation
• Version Model Number: 807401215
• Company DUNS: 135179237
• Company Name: VOLCANO 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	00845225012045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071554

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2016-09-19

On-Brand Devices [s5i Imaging System Workstation]

• 00184360000686: 807401001
• 00845225012595: 410-3600.07
• 00845225012588: 410-3600.06
• 00845225012045: 807401215
• 00845225012038: 807401200
• 00845225010232: 807400015