ACIST CVi® Contrast Delivery System

GUDID 40841716102194

CVi Injector p/n 801091-001 Contents: CVi Injector Head, Bed Mount, & Power Supply

ACIST MEDICAL SYSTEMS, INC.

Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 40841716102194
• NIH Device Record Key: 5b9b435f-b594-47a8-a39c-73290a1b157d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST CVi® Contrast Delivery System
• Version Model Number: 016612
• Company DUNS: 926684994
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	40841716102194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191060

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-25
• Device Publish Date: 2019-10-17

On-Brand Devices [ACIST CVi® Contrast Delivery System]

• 40841716101883: CVi Injector p/n 800620-024 Contents: CVi Injector Head (Siemens), Control Panel, & Power Supply
• 40841716101876: CVi Injector p/n 800620-023 Contents: CVi Injector Head, Control Panel, & Power Supply
• 40841716102194: CVi Injector p/n 801091-001 Contents: CVi Injector Head, Bed Mount, & Power Supply