ACIST HDi™ Cart

GUDID 10841716103992

ACIST MEDICAL SYSTEMS, INC.

Cardiovascular ultrasound imaging system

• Primary Device ID: 10841716103992
• NIH Device Record Key: 66912c9f-4717-4298-bd39-9649d1dbf29d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST HDi™ Cart
• Version Model Number: 017991
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	10841716103992 [Primary]
GS1	30841716103996 [Package]; 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: 2026-03-12
• Device Publish Date: 2026-03-04

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

• 10841716103992 - ACIST HDi™ Cart: 2026-03-12
• 10841716103992 - ACIST HDi™ Cart: 2026-03-12
• 10841716103442 - CT Exprès Bottle Spike A: 2025-12-17 CT Exprès Bottle Spike A
• 10841716103466 - CT Exprès Day Set III HP: 2025-12-17 CT Exprès Day Set III HP
• 10841716101875 - ACIST CVi® Contrast Delivery System Injector Head: 2025-12-08 CVi Injector, p/n 700706-010
• 10841716101882 - ACIST CVi® Contrast Delivery System Injector Head: 2025-12-08 CVi Injector (Siemens), p/n 700708-010
• 10841716101899 - ACIST CVi® Contrast Delivery System Control Panel: 2025-12-08 ACIST CVi® Contrast Delivery System Control Panel, p/n 701557-002
• 10841716101905 - ACIST CVi® Contrast Delivery System Power Supply: 2025-12-08 CVi Power Supply p/n 701340-003
• 10841716103480 - CT Exprès Patient Set: 2025-08-25 CT Exprès Patient Set