ReSolve®, Revolution™ RBDC-10-REV/A

GUDID 10884450057480

Merit Medical Systems, Inc.

Biliary drainage catheter

• Primary Device ID: 10884450057480
• NIH Device Record Key: e15370be-65b1-4bd9-a6bf-4165a910e45c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReSolve®, Revolution™
• Version Model Number: 00884450057483
• Catalog Number: RBDC-10-REV/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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450057483 [Primary]
GS1	10884450057480 [Package]; Contains: 00884450057483; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141408

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-01

On-Brand Devices [ReSolve®, Revolution™]

• 10884450086022: 00884450086025
• 10884450057480: 00884450057483
• 10884450030063: 00884450030066
• 10884450026127: 00884450026120
• 10884450026110: 00884450026113
• 10884450023829: 00884450023822
• 10884450022969: 00884450022962
• 10884450022235: 00884450022238
• 10884450022204: 00884450022207
• 10884450019792: 00884450019795
• 10884450086039: 00884450086032
• 10884450414757: 00884450414750
• 10884450057831: 00884450057834
• 10884450076702: 00884450076705