ACIST RXi® System and Accessories

GUDID 40841716101746

RXi System Overpack, p/n 800981-004 Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables)

ACIST MEDICAL SYSTEMS, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 40841716101746
• NIH Device Record Key: f6ebf01a-59d2-4042-8ef4-90b16e372c7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST RXi® System and Accessories
• Version Model Number: 014666
• 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: true
• 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	40841716101746 [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: 2018-09-03
• Device Publish Date: 2018-08-02

On-Brand Devices [ACIST RXi® System and Accessories]

• 40841716101746: RXi System Overpack, p/n 800981-004 Contents: Console, Power Supply, Bed Mount, USB Drive, and A
• 40841716100763: RXi System Overpack, p/n 801005-002 Contents: Refurbished Console, Power Supply, Bed Mount, USB
• 40841716100732: RXi System Overpack, p/n 801027-001 Contents: Console, Power Supply, Bed Mount, USB Drive, and A
• 40841716100671: RXi System Overpack, p/n 800981-003 Contents: Console, Power Supply, Bed Mount, USB Drive, and A
• 40841716100664: RXi System Overpack, p/n 800981-002 Contents: Console, Power Supply, Bed Mount, USB Drive, and A