DuraFlow™ 2 H787103012195

GUDID 10884450795061

Merit Medical Systems, Inc.

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 10884450795061
• NIH Device Record Key: 7ae776c6-e846-4685-81bb-4be450360a82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraFlow™ 2
• Version Model Number: A
• Catalog Number: H787103012195
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450795064 [Primary]
GS1	10884450795061 [Package]; Contains: 00884450795064; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110936

FDA Product Code

• MSD: Catheter, hemodialysis, implanted

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: 2024-07-10
• Device Publish Date: 2024-07-02

On-Brand Devices [DuraFlow™ 2]

• 10884450795061: A
• 10884450786120: A