ACIST RXi® Mini System Overpack

GUDID 40841716101753

RXi Mini System, p/n 801042-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (Power Cord and Cables)

ACIST MEDICAL SYSTEMS, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 40841716101753
• NIH Device Record Key: 59fc450e-6b8b-48f9-a72d-d693b3a54482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST RXi® Mini System Overpack
• Version Model Number: 018599
• 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	40841716101753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172216

FDA Product Code

• DRQ: Amplifier And Signal Conditioner, Transducer Signal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-25

On-Brand Devices [ACIST RXi® Mini System Overpack]

• 40841716101753: RXi Mini System, p/n 801042-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (Po
• 40841716101586: RXi Mini System, p/n 801075-001 Processing Unit, Navvus Interface, Mounts, and Accessory Box (P