DuraMax® H787103028095

GUDID 00884450794630

Merit Medical Systems, Inc.

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 00884450794630
• NIH Device Record Key: a6953198-a8c1-42c9-b26d-f3ffa607772b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraMax®
• Version Model Number: A
• Catalog Number: H787103028095
• 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	00884450794630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101843

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: 2024-08-09
• Device Publish Date: 2024-08-01

On-Brand Devices [DuraMax®]

• 10884450786175: A
• 10884450786137: A
• 10884450794699: A
• 10884450786182: A
• 00884450794630: A
• 00884450794548: A
• 10884450794750: A
• 00884450794623: A
• 00884450794562: A
• 00884450794586: A
• 00884450794661: A
• 00884450794555: A
• 10884450786168: A
• 10884450794798: A
• 10884450794774: A
• 00884450794678: A
• 00884450794715: A
• 00884450794609: A