CORE FM CART

GUDID 00845255012657

VOLCANO CORPORATION

Intravascular haemodynamic monitoring system

• Primary Device ID: 00845255012657
• NIH Device Record Key: f514bfbf-41ee-4ec6-af5f-4b634ce0b4d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE FM CART
• Version Model Number: 410-0100.11
• 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	00845255012657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152582

FDA Product Code

• DSK: Computer, Blood-Pressure

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

On-Brand Devices [CORE FM CART]

• 00845255012657: 410-0100.11
• 00845225012656: 410-0100.11