ACIST HDi® System Console

GUDID 10841716101851

HDi System Console, p/n 701460-005

ACIST MEDICAL SYSTEMS, INC.

Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system

• Primary Device ID: 10841716101851
• NIH Device Record Key: b19c19f0-a51c-4882-9ca3-fbac65b0e4e1
• Commercial Distribution Discontinuation: 2019-01-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACIST HDi® System Console
• Version Model Number: 017987
• 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	10841716101851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173063

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-09
• Device Publish Date: 2018-09-04

On-Brand Devices [ACIST HDi® System Console]

• 10841716102148: HDi System Console, p/n 701460-006
• 10841716101851: HDi System Console, p/n 701460-005
• 30841716100254: HDi System Console, p/n 701460-004