ComboMap Pressure and Flow System 80745001

GUDID 00084522501874

VOLCANO CORPORATION

Intravascular haemodynamic monitoring system

• Primary Device ID: 00084522501874
• NIH Device Record Key: 44758c28-79b3-49d4-9e2b-63583f3d5c66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComboMap Pressure and Flow System
• Version Model Number: 6800
• Catalog Number: 80745001
• Company DUNS: 135179237
• Company Name: VOLCANO CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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	00084522501874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041134

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: 2016-12-08

On-Brand Devices [ComboMap Pressure and Flow System ]

• 00084522501874: 6800
• 00845225010874: 6800