ACIST HDi® HD IVUS System

GUDID 40841716103511

HDi System Overpack Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply

ACIST MEDICAL SYSTEMS, INC.

Cardiovascular ultrasound imaging system

• Primary Device ID: 40841716103511
• NIH Device Record Key: 801d3b9a-eb98-4119-b9ad-2c2c2faec1c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST HDi® HD IVUS System
• Version Model Number: 017986
• Company DUNS: 926684994
• Company Name: ACIST 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: 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	40841716103511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193183

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [ACIST HDi® HD IVUS System]

• 40841716102101: ACI Hardware, HDi System p/n 801085-001 Contents: ACI Hardware
• 40841716102057: HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001 Contents: System Console, Linear T
• 40841716101982: HDi System Overpack p/n 801029-002 Contents: System Console, Linear Translation System (LTS), Pa
• 40841716101869: HDi System Overpack p/n 800994-004 Contents: System Console, Linear Translation System (LTS), Pa
• 40841716101180: HDi System Overpack p/n 800994-002 Contents: System Console, Linear Translation System (LTS), Pa
• 40841716100749: HDi System Overpack p/n 801029-001 Contents: System Console, Linear Translation System (LTS), Pa
• 40841716100251: HDi System Overpack p/n 800994-003 Contents: System Console, Linear Translation System (LTS), Pa
• 40841716103511: HDi System Overpack Contents: System Console, Linear Translation System (LTS), Patient Interface