ACIST HDi® System Console

GUDID 30841716100254

HDi System Console, p/n 701460-004

ACIST MEDICAL SYSTEMS, INC.

Cardiovascular ultrasound imaging system

• Primary Device ID: 30841716100254
• NIH Device Record Key: 36e90fe4-9a15-4479-97d6-828c499e7927
• Commercial Distribution Discontinuation: 2018-07-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACIST HDi® System Console
• Version Model Number: 017986
• 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	10841716100250 [Primary]
GS1	30841716100254 [Package]; Contains: 10841716100250; Package: Shelf box [1 Units]; Discontinued: 2018-07-30; Not in Commercial Distribution

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: 3
• Public Version Date: 2024-05-09
• Device Publish Date: 2016-09-09

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
• 30841716103514: HDi System Console