ACIST HDi® System Console

GUDID 30841716103514

HDi System Console

ACIST MEDICAL SYSTEMS, INC.

Cardiovascular ultrasound imaging system

• Primary Device ID: 30841716103514
• NIH Device Record Key: 3797df75-ee49-416e-8161-64faffa6617f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST HDi® System Console
• Version Model Number: 017987
• 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: false
• 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	10841716103510 [Primary]
GS1	30841716103514 [Package]; Contains: 10841716103510; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193183

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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® System Console]

• 10841716102148: HDi System Console, p/n 701460-006
• 10841716101851: HDi System Console, p/n 701460-005
• 30841716100254: HDi System Console, p/n 701460-004
• 30841716103514: HDi System Console