ACIST HDi® Linear Translation System (LTS)

GUDID 30841716100698

HDi LTS, p/n 701457-004

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: 30841716100698
• NIH Device Record Key: 5b9c46c6-50ca-4c0e-891a-46391e1eb60b
• Commercial Distribution Discontinuation: 2020-01-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACIST HDi® Linear Translation System (LTS)
• Version Model Number: 017988
• 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	10841716100694 [Primary]
GS1	30841716100698 [Package]; Contains: 10841716100694; Package: Shipper box [1 Units]; Discontinued: 2020-01-14; 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: 2017-02-17

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• 30841716100254 - ACIST HDi® System Console: 2024-05-09 HDi System Console, p/n 701460-004
• 30841716100698 - ACIST HDi® Linear Translation System (LTS): 2024-05-09HDi LTS, p/n 701457-004
• 30841716100698 - ACIST HDi® Linear Translation System (LTS): 2024-05-09 HDi LTS, p/n 701457-004
• 30841716101176 - ACIST HDi® Power Supply: 2024-05-09 HDi Power Supply, p/n 701560-002