ACIST HDi® Cart

GUDID 30841716101206

HDi Cart, p/n 205046-005

ACIST MEDICAL SYSTEMS, INC.

Cardiovascular ultrasound imaging system

• Primary Device ID: 30841716101206
• NIH Device Record Key: 6bb2fade-3825-4c6e-8b00-8e781621e177
• Commercial Distribution Discontinuation: 2020-01-14
• Commercial Distribution Status: Not 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: Labeling does not contain MRI Safety Information
• 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	10841716101202 [Primary]
GS1	30841716101206 [Package]; Contains: 10841716101202; Package: Shelf Box [1 Units]; Discontinued: 2020-01-14; Not in Commercial Distribution

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-04-22
• Device Publish Date: 2016-09-09

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

• 10841716103480 - CT Exprès Patient Set: 2025-08-25 CT Exprès Patient Set
• 10841716103602 - ACIST Kodama® Coronary Imaging Catheter: 2025-08-22 Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag
• 10841716103244 - ACIST Navvus®II Catheter: 2025-01-28 Navvus II Catheter, p/n 701711-003
• 10841716103763 - ACIST RXi® Console with dPR: 2025-01-28 RXi Console with dPR, US (p/n: 800939-010 )
• 40841716103757 - ACIST RXi® System with dPR: 2025-01-28 RXi System with dPR, US (p/n: 800981-010 )
• 30841716103514 - ACIST HDi® System Console: 2024-11-21 HDi System Console
• 30841716103521 - ACIST HDi® Power Supply: 2024-11-21 HDi Power Supply
• 40841716103511 - ACIST HDi® HD IVUS System: 2024-11-21 HDi System Overpack Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply