Dial Ease FCL-182-00

GUDID 10884450258191

Merit Medical

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450258191
• NIH Device Record Key: ce4806bb-5a09-43b1-85c0-890af0556e43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dial Ease
• Version Model Number: 00884450258194
• Catalog Number: FCL-182-00
• 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	00884450258194 [Primary]
GS1	10884450258191 [Package]; Contains: 00884450258194; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043438

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: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-03-07

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• 00884450313732 - Prelude Prestige™: 2021-10-11
• 00884450313800 - Prelude Prestige™: 2021-10-11
• 00884450313831 - Prelude Prestige™: 2021-10-11
• 00884450313855 - Prelude Prestige™: 2021-10-11
• 00884450451410 - HeartSpan®: 2021-01-01