ACIST CVi® Angiographic Injection System Power Supply

GUDID 10841716100632

CVi Power Supply p/n 701340-002

ACIST MEDICAL SYSTEMS, INC.

Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 10841716100632
• NIH Device Record Key: 5abe52a9-182d-4499-9ff5-2211965ee037
• Commercial Distribution Discontinuation: 2018-06-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACIST CVi® Angiographic Injection System Power Supply
• Version Model Number: 017906
• 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	10841716100632 [Primary]
GS1	30841716100636 [Package]; Package: Shelf box [1 Units]; Discontinued: 2018-06-12; Not in Commercial Distribution

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2024-05-17
• Device Publish Date: 2016-09-09

Devices Manufactured by ACIST MEDICAL SYSTEMS, INC.

• 10841716103244 - ACIST Navvus®II Catheter: 2025-01-28 Navvus II Catheter, p/n 701711-003
• 10841716103763 - ACIST RXi® Console with dPR: 2025-01-28 RXi Console with dPR, US (p/n: 800939-010 )
• 40841716103757 - ACIST RXi® System with dPR: 2025-01-28 RXi System with dPR, US (p/n: 800981-010 )
• 30841716103514 - ACIST HDi® System Console: 2024-11-21 HDi System Console
• 30841716103521 - ACIST HDi® Power Supply: 2024-11-21 HDi Power Supply
• 40841716103511 - ACIST HDi® HD IVUS System: 2024-11-21 HDi System Overpack Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply
• 20841716100004 - ACIST Navvus® Catheter: 2024-06-12 Navvus Catheter, p/n 701481-002
• 10841716100014 - ACIST Navvus® Catheter: 2024-06-12 Navvus Catheter, p/n 701481-003