CT Exprès Bottle Spike A

GUDID 10841716103442

CT Exprès Bottle Spike A

ACIST MEDICAL SYSTEMS, INC.

Basic intravenous administration set, noninvasive

• Primary Device ID: 10841716103442
• NIH Device Record Key: 3cd5e07e-f652-4273-bee9-bbb5b25351f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT Exprès Bottle Spike A
• Version Model Number: 640458
• 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	10841716103442 [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: 2025-12-17
• Device Publish Date: 2025-12-09

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

• 10841716103442 - CT Exprès Bottle Spike A: 2025-12-17CT Exprès Bottle Spike A
• 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
• 10841716103602 - ACIST Kodama® Coronary Imaging Catheter: 2025-08-22 Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag