Hydrophilic Prelude SNAP™ PLSH-1009/A

GUDID 00884450495100

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00884450495100
• NIH Device Record Key: 523d6045-77f4-4280-8087-dc33ac2daef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrophilic Prelude SNAP™
• Version Model Number: 10884450495107
• Catalog Number: PLSH-1009/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	00884450495100 [Unit of Use]
GS1	10884450495107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152381

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: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [Hydrophilic Prelude SNAP™]

• 00884450495056: 10884450495053
• 00884450495049: 10884450495046
• 00884450495100: 10884450495107
• 00884450495087: 10884450495084
• 00884450495445: 10884450495442
• 00884450495476: 10884450495473
• 00884450495469: 10884450495466
• 00884450495490: 10884450495497
• 00884450495506: 10884450495503
• 00884450495452: 10884450495459
• 00884450495513: 10884450495510
• 00884450495520: 10884450495527
• 00884450495551: 10884450495558
• 00884450495544: 10884450495541
• 00884450495537: 10884450495534
• 00884450495483: A