IntelliSystem®

GUDID 10884450006594

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 10884450006594
• NIH Device Record Key: 7674635c-892f-404e-892d-9a08bef9949f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSystem®
• Version Model Number: 00884450006597
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450006597 [Primary]
GS1	10884450006594 [Package]; Contains: 00884450006597; Package: [5 Units]; In Commercial Distribution
GS1	20884450006591 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884913

FDA Product Code

• DXT: INJECTOR AND SYRINGE, ANGIOGRAPHIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-24

On-Brand Devices [IntelliSystem®]

• 20884450298002: 00884450298008
• 10884450297992: 00884450297995
• 10884450297985: 00884450297988
• 10884450236977: 00884450236970
• 10884450236892: 00884450236895
• 10884450028039: 00884450028032
• 10884450024598: 00884450024591
• 10884450021467: 00884450021460
• 10884450006594: 00884450006597
• 10884450298012: 00884450298015