Prelude SNAP™ PLS-1009.5/A

GUDID 00884450468036

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00884450468036
• NIH Device Record Key: 9532e123-f6b3-4370-bae9-8cfc9785af5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude SNAP™
• Version Model Number: 10884450468033
• Catalog Number: PLS-1009.5/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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450468036 [Unit of Use]
GS1	10884450468033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143255

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [Prelude SNAP™]

• 20884450467989: 10884450467982
• 20884450468108: 10884450468101
• 20884450468016: 10884450468019
• 20884450467996: 10884450467999
• 20884450467958: 10884450467951
• 20884450468122: 10884450468125
• 20884450468047: 10884450468040
• 00884450468067: 10884450468064
• 00884450468036: 10884450468033
• 00884450468098: 10884450468095
• 00884450468074: 10884450468071
• 00884450468111: 10884450468118
• 00884450468050: 10884450468057
• 00884450489758: 10884450489755
• 00884450489611: 10884450489618
• 00884450489628: 10884450489625
• 00884450489598: 10884450489595
• 00884450489567: 10884450489564
• 00884450468142: 10884450468149
• 00884450489574: 10884450489571
• 00884450468081: 10884450468088
• 00884450489604: 10884450489601
• 00884450468005: 10884450468002
• 00884450468159: 10884450468156
• 00884450489772: 10884450489779
• 00884450489550: 10884450489557
• 00884450468135: 10884450468132
• 00884450489666: 10884450489663
• 00884450489789: 10884450489786
• 00884450489765: 10884450489762
• 00884450489796: 10884450489793
• 00884450489581: 10884450489588
• 00884450489635: 10884450489632
• 00884450489659: A