Merit SwiftNINJA® MIV-20500/A

GUDID 00884450278505

Merit Medical Systems, Inc.

Vascular microcatheter

• Primary Device ID: 00884450278505
• NIH Device Record Key: 997c73d5-78c8-491d-ab0a-701714dd6e70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merit SwiftNINJA®
• Version Model Number: 00884450278505
• Catalog Number: MIV-20500/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: false
• 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	00884450278505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161921

FDA Product Code

• KRA: Catheter, continuous flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-12-07

On-Brand Devices [Merit SwiftNINJA®]

• 00884450323878: 00884450323878
• 00884450297551: 00884450297551
• 00884450278505: 00884450278505
• 00884450324004: 00884450324004
• 10884450357108: 00884450357101
• 10884450357092: 00884450357095