RXi® Console Cable

GUDID 30841716102845

Cable, Transducer Pass-Through, 1 kOhm Excite Load, p/n 801275-001

ACIST MEDICAL SYSTEMS, INC.

Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer

• Primary Device ID: 30841716102845
• NIH Device Record Key: 3ec9c762-95f3-4121-8d6d-992db779e722
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RXi® Console Cable
• Version Model Number: 018726
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	30841716102845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132474

FDA Product Code

• OBI: Catheter, Pressure Monitoring, Cardiac

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: 2021-06-25
• Device Publish Date: 2021-06-17

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

• 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
• 30841716100384 - ACIST RXi® System: 2024-06-12 RXi System Console, p/n 701309-008
• 30841716101732 - ACIST RXi® System: 2024-06-12 RXi System Console, p/n 701640-001
• 10841716102421 - AngioTouch® Kit: 2024-06-07 Model AT X65
• 10841716103251 - AngioTouch® Kit: 2024-06-07 Model AT X65L
• 30841716102524 - A1000V Single Use Syringe Kit: 2024-06-05 A1000V Single Use Syringe Kit Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.
• 30841716100070 - ACIST CVi® Cart: 2024-05-31 CVi Cart, p/n 701351-001