Merit PAK™ PAKS4NPD4/A

GUDID 10884450275693

Merit Medical Systems, Inc.

Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use

• Primary Device ID: 10884450275693
• NIH Device Record Key: cfc78b6a-888b-42ac-99ed-d65939baf84b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merit PAK™
• Version Model Number: 00884450275696
• Catalog Number: PAKS4NPD4/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	00884450275696 [Primary]
GS1	10884450275693 [Package]; Contains: 00884450275696; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031691

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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: 2018-12-03
• Device Publish Date: 2018-11-01

On-Brand Devices [Merit PAK™]

• 10884450275716: 00884450275719
• 10884450275693: 00884450275696
• 10884450275624: 00884450275627
• 10884450275686: 00884450275689
• 10884450275662: 00884450275665
• 10884450275723: 00884450275726
• 10884450275730: 00884450275733
• 20884450275577: 10884450275570
• 20884450275560: 10884450275563
• 10884450587130: 00884450587133
• 10884450587147: 00884450587140
• 10884450587123: 00884450587126
• 10884450587192: 00884450587195
• 10884450587178: 00884450587171
• 10884450587154: 00884450587157
• 10884450587161: 00884450587164