DuraFlow 2 H787103012015

GUDID 10884450786113

Merit Medical Systems, Inc.

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 10884450786113
• NIH Device Record Key: fa3bd166-261a-43af-a851-8fc88e90263b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraFlow 2
• Version Model Number: A
• Catalog Number: H787103012015
• 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	00884450786116 [Primary]
GS1	10884450786113 [Package]; Contains: 00884450786116; 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: 2024-05-01
• Device Publish Date: 2024-04-23

Devices Manufactured by Merit Medical Systems, Inc.

• 00884450846438 - Merit Medical®: 2024-11-15
• 20884450848733 - Merit Medical®: 2024-11-15
• 20884450614703 - Prelude®: 2024-11-15
• 10884450617974 - Performa®: 2024-11-14
• 20884450834620 - Prelude IDeal™: 2024-11-14
• 00884450780138 - Arcadia™: 2024-11-11
• 20884450821262 - High Pressure Tubing, Keep™: 2024-11-11
• 20884450851436 - Merit Medical®: 2024-11-11