Prelude ACT™ PSI-6F-11-038ACT/D

GUDID 20884450602915

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

• Primary Device ID: 20884450602915
• NIH Device Record Key: 0faf03d9-5bec-43a4-834f-c220e7cc6bcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude ACT™
• Version Model Number: 10884450602918
• Catalog Number: PSI-6F-11-038ACT/D
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 5
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450602911 [Unit of Use]
GS1	10884450602918 [Primary]
GS1	20884450602915 [Package]; Contains: 10884450602918; Package: [4 Units]; In Commercial Distribution

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: 2021-11-15
• Device Publish Date: 2021-11-05

On-Brand Devices [Prelude ACT™]

• 20884450331938: 10884450331931
• 20884450331914: 10884450331917
• 20884450331815: 10884450331818
• 20884450331730: 10884450331733
• 20884450331624: 10884450331627
• 20884450331525: 10884450331528
• 20884450331501: 10884450331504
• 20884450331839: 10884450331832
• 20884450602915: 10884450602918
• 20884450615205: 10884450615208
• 20884450614802: 10884450614805
• 20884450614727: 10884450614720
• 20884450614680: 10884450614683
• 20884450614482: 10884450614485
• 20884450614178: 10884450614171
• 20884450614437: 10884450614430
• 20884450615182: 10884450615185