PreludeSYNC™ SRB20EVOAC

GUDID 10884450445201

Merit Medical Systems, Inc.

Vascular compressor, external

• Primary Device ID: 10884450445201
• NIH Device Record Key: c1b6e929-62d6-45f2-9312-cef857088180
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreludeSYNC™
• Version Model Number: 10884450445201
• Catalog Number: SRB20EVOAC
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 10
• 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	00884450445204 [Unit of Use]
GS1	10884450445201 [Primary]

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: 2019-10-11
• Device Publish Date: 2019-10-03

On-Brand Devices [PreludeSYNC™]

• 20884450411494: 10884450411497
• 20884450411517: 10884450411510
• 20884450411197: 10884450411190
• 10884450445201: 10884450445201
• 20884450525573: 10884450525576
• 20884450525214: 10884450525217
• 20884450411500: 10884450411503
• 10884450363673: 10884450363673
• 10884450363659: 10884450363659
• 20884450360297: 10884450360290
• 20884450358942: 10884450358945
• 20884450358935: 10884450358938
• 20884450286900: 10884450286903
• 20884450286894: 10884450286897
• 20884450286887: 10884450286880
• 20884450286870: 10884450286873
• 10884450286538: 10884450286538
• 20884450567825: 10884450567828
• 20884450567788: 10884450567781
• 20884450567832: 10884450567835
• 20884450567887: 10884450567880