ACIST RXi® System

GUDID 30841716100384

RXi System Console, p/n 701309-008

ACIST MEDICAL SYSTEMS, INC.

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• Primary Device ID: 30841716100384
• NIH Device Record Key: 0ef0446c-fc46-482a-b134-a8e78ddfdf48
• Commercial Distribution Discontinuation: 2023-06-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACIST RXi® System
• 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: 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	10841716101257 [Primary]
GS1	30841716100384 [Package]; Contains: 10841716101257; Package: Shelf box [1 Units]; Discontinued: 2023-06-23; Not in Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-06-12
• Device Publish Date: 2016-09-09

On-Brand Devices [ACIST RXi® System]

• 30841716101732: RXi System Console, p/n 701640-001
• 30841716100384: RXi System Console, p/n 701309-008