RXi® Mini Navvus Interface Cable

GUDID 30841716101817

Navvus Interface to Processing Unit Cable, p/n 301883-003

ACIST MEDICAL SYSTEMS, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 30841716101817
• NIH Device Record Key: c7e48105-8ff0-42d7-8202-c2df69dbcdc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RXi® Mini Navvus Interface Cable
• Version Model Number: 018596
• 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: true
• 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	30841716101817 [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: 2017-09-27

On-Brand Devices [RXi® Mini Navvus Interface Cable]

• 30841716101817: Navvus Interface to Processing Unit Cable, p/n 301883-003
• 30841716101800: Navvus Interface to Processing Unit Cable, p/n 301883-002
• 30841716101770: Navvus Interface to Processing Unit Cable, p/n 301883-001