Prelude EASE™ Hydrophilic Sheath K18-00019

GUDID 10884450288013

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450288013
• NIH Device Record Key: d697bee6-beaa-4c4f-a2d7-711f9dd8b690
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude EASE™ Hydrophilic Sheath
• Version Model Number: 00884450288016
• Catalog Number: K18-00019
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00884450288016 [Primary]
GS1	10884450288013 [Package]; Contains: 00884450288016; Package: [5 Units]; In Commercial Distribution
GS1	20884450288010 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• OEX: Cardiovascular catheter sheath introducer kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-09-13

On-Brand Devices [Prelude EASE™ Hydrophilic Sheath]

• 10884450312671: 00884450312674
• 10884450288013: 00884450288016
• 20884450288003: 00884450288009
• 10884450284534: 00884450284537
• 20884450284524: 00884450284520
• 20884450284517: 00884450284513