DuraFlow2 H787103012245

GUDID 00884450795101

Merit Medical Systems, Inc.

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 00884450795101
• NIH Device Record Key: aadf44c5-336c-4b96-9e60-af7768d49e1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraFlow2
• Version Model Number: A
• Catalog Number: H787103012245
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450795101 [Primary]

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