Surfacer® 600200

GUDID 00884450762158

Merit Medical Systems, Inc.

Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set Central venous catheter inside-out introduction set

• Primary Device ID: 00884450762158
• NIH Device Record Key: f18b92be-6f78-4087-b6ab-a93d4fdb8a17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surfacer®
• Version Model Number: C
• Catalog Number: 600200
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450762158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190038

FDA Product Code

• QJH: Reverse central venous recanalization system

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: 2024-03-11
• Device Publish Date: 2024-03-02

Devices Manufactured by Merit Medical Systems, Inc.

• 00884450478196 - Merit Maestro®: 2024-04-25
• 10884450770655 - Performa®: 2024-04-25
• 00884450478264 - Merit Maestro®: 2024-04-24
• 00884450478288 - Merit Maestro®: 2024-04-24
• 10884450697259 - ProGuide™: 2024-04-24
• 10884450712303 - Impress®: 2024-04-24
• 00884450819111 - Merit Medical®: 2024-04-24
• 20884450709188 - Prelude®: 2024-04-24