CT Exprès Patient Set

GUDID 10841716103480

CT Exprès Patient Set

ACIST MEDICAL SYSTEMS, INC.

Basic intravenous administration set, noninvasive

• Primary Device ID: 10841716103480
• NIH Device Record Key: e1584b56-8d3a-4e1a-8175-b1fc195a652f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT Exprès Patient Set
• Version Model Number: 640457
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	10841716103480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151048

FDA Product Code

• IZQ: Injector, Contrast Medium, Automatic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-25
• Device Publish Date: 2025-08-15

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

• 10841716103480 - CT Exprès Patient Set: 2025-08-25CT Exprès Patient Set
• 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