PreludeSYNC EVO™ SRB24LBAC/A

GUDID 20884450462946

Merit Medical Systems, Inc.

Vascular compressor, external

• Primary Device ID: 20884450462946
• NIH Device Record Key: 1912430f-6df9-4662-946d-03e7550100a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreludeSYNC EVO™
• Version Model Number: 10884450462949
• Catalog Number: SRB24LBAC/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 5
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450462942 [Unit of Use]
GS1	10884450462949 [Primary]
GS1	20884450462946 [Package]; Contains: 10884450462949; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180723

FDA Product Code

• DXC: CLAMP, VASCULAR

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: 2021-01-26
• Device Publish Date: 2021-01-18

On-Brand Devices [PreludeSYNC EVO™]

• 20884450400443: 10884450400446
• 20884450462946: 10884450462949
• 20884450567870: 10884450567873
• 20884450567818: 10884450567811
• 20884450462953: 10884450462956
• 20884450400467: 10884450400460