ACIST RXi® Console with dPR

GUDID 10841716103763

RXi Console with dPR, US (p/n: 800939-010 )

ACIST MEDICAL SYSTEMS, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 10841716103763
• NIH Device Record Key: d1694a4a-4265-49a9-be5a-e9a438fb5b4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST RXi® Console with dPR
• Version Model Number: 019994
• 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: 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	10841716103763 [Primary]
GS1	30841716103767 [Package]; Package: Console, packaged [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233904

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

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: 2025-01-28
• Device Publish Date: 2025-01-20

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

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• 10841716103763 - ACIST RXi® Console with dPR: 2025-01-28RXi Console with dPR, US (p/n: 800939-010 )
• 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
• 20841716100004 - ACIST Navvus® Catheter: 2024-06-12 Navvus Catheter, p/n 701481-002
• 10841716100014 - ACIST Navvus® Catheter: 2024-06-12 Navvus Catheter, p/n 701481-003