CardiaGuide™ FCL20102

GUDID 00884450504802

Merit Medical Systems, Inc.

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• Primary Device ID: 00884450504802
• NIH Device Record Key: b3abbdac-50a1-4ccc-b1d0-20c88ff22dee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardiaGuide™
• Version Model Number: 00884450504802
• Catalog Number: FCL20102
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450504802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132720

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-03
• Device Publish Date: 2021-10-26

On-Brand Devices [CardiaGuide™]

• 00884450504819: 00884450504819
• 00884450504796: 00884450504796
• 00884450504789: 00884450504789
• 00884450504802: 00884450504802