Worley™ Adv. LVI WORLVI-75-5-62-55-RE/A

GUDID 10884450483951

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450483951
• NIH Device Record Key: 20fa8f9a-fa7e-472c-8f03-898bc18f013f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Worley™ Adv. LVI
• Version Model Number: 00884450483954
• Catalog Number: WORLVI-75-5-62-55-RE/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• 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	00884450483954 [Primary]
GS1	10884450483951 [Package]; Contains: 00884450483954; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152116

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: 2020-08-20
• Device Publish Date: 2020-08-12

On-Brand Devices [Worley™ Adv. LVI]

• 10884450483951: 00884450483954
• 10884450483913: 00884450483916
• 10884450483920: 00884450483923
• 10884450483906: 00884450483909
• 10884450483944: 00884450483947
• 10884450483890: 00884450483893
• 10884450483883: 00884450483886
• 10884450483937: 00884450483930