PreludeSYNC EVO™ SRB24LBAC

GUDID 20884450400443

Merit Medical Systems, Inc.

Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external Vascular compressor, external

• Primary Device ID: 20884450400443
• NIH Device Record Key: 84dfc1f8-83c1-4f5b-a80f-a586ed11dc10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreludeSYNC EVO™
• Version Model Number: 10884450400446
• Catalog Number: SRB24LBAC
• 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 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450400449 [Unit of Use]
GS1	10884450400446 [Primary]
GS1	20884450400443 [Package]; Contains: 10884450400446; 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: 2019-06-24
• Device Publish Date: 2019-06-14

On-Brand Devices [PreludeSYNC EVO™]

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