Transvalvular Insertion Tool (TVI) TVI-07

GUDID 10884450544102

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450544102
• NIH Device Record Key: 8f563d71-96a6-467f-bef7-1e6091f5dc12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transvalvular Insertion Tool (TVI)
• Version Model Number: 00884450544105
• Catalog Number: TVI-07
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450544105 [Primary]
GS1	10884450544102 [Package]; Contains: 00884450544105; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• DWS: INSTRUMENTS, SURGICAL, CARDIOVASCULAR

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: 2024-03-20
• Device Publish Date: 2021-05-28

Devices Manufactured by Merit Medical Systems, Inc.

• 00884450478196 - Merit Maestro®: 2024-04-25
• 10884450770655 - Performa®: 2024-04-25
• 00884450478264 - Merit Maestro®: 2024-04-24
• 00884450478288 - Merit Maestro®: 2024-04-24
• 10884450697259 - ProGuide™: 2024-04-24
• 10884450712303 - Impress®: 2024-04-24
• 00884450819111 - Merit Medical®: 2024-04-24
• 20884450709188 - Prelude®: 2024-04-24