s5 FFR Patient Interface Module

GUDID 00845225011239

VOLCANO CORPORATION

Intravascular haemodynamic monitoring system

• Primary Device ID: 00845225011239
• NIH Device Record Key: 5a385dff-2295-4055-8208-ebeb578f65b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s5 FFR Patient Interface Module
• Version Model Number: 807344001
• 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	00845225011239 [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: 2016-09-12

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• 00845225012656 - CORE FM CART: 2020-06-02
• 00845225010874 - ComboMap Pressure and Flow System: 2020-01-01
• 00845225002565 - Pioneer Plus Catheter: 2019-03-21