CardiaGuide™ FCL-201-03

GUDID 00884450407486

Merit Medical

Cardiac transseptal access set

• Primary Device ID: 00884450407486
• NIH Device Record Key: dae57902-fbcf-4136-b280-68e865cde65b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardiaGuide™
• Version Model Number: 00884450407486
• Catalog Number: FCL-201-03
• Company DUNS: 065673912
• Company Name: Merit Medical
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450407486 [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: 2020-04-17
• Device Publish Date: 2020-04-09

On-Brand Devices [CardiaGuide™]

• 00884450407479: 00884450407479
• 00884450407448: 00884450407448
• 00884450407424: 00884450407424
• 00884450407486: 00884450407486