Worley™ Adv. LVI WORLVI-75-5-62-55-HO

GUDID 10884450284589

Merit Medical

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450284589
• NIH Device Record Key: 893a4f8b-d4c4-43c0-9ee3-83f645261e51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Worley™ Adv. LVI
• Version Model Number: 00884450284582
• Catalog Number: WORLVI-75-5-62-55-HO
• Company DUNS: 065673912
• Company Name: Merit Medical
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450284582 [Primary]
GS1	10884450284589 [Package]; Contains: 00884450284582; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-10-16

On-Brand Devices [Worley™ Adv. LVI]

• 10884450284657: 00884450284650
• 10884450284640: 00884450284643
• 10884450284633: 00884450284636
• 10884450284589: 00884450284582
• 10884450169824: 00884450169827
• 10884450169817: 00884450169810
• 10884450169800: 00884450169803
• 10884450169794: 00884450169797