B2000 Automated Manifold Kit

GUDID 30841716100261

Model B2000 p/n 700303-011 Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system manifold kit

• Primary Device ID: 30841716100261
• NIH Device Record Key: 4d0e3eb0-6e2c-4584-a21e-75c9e0b3f782
• Commercial Distribution Discontinuation: 2018-05-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: B2000 Automated Manifold Kit
• Version Model Number: 014621
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	10841716100267 [Primary]
GS1	30841716100261 [Package]; Contains: 10841716100267; Package: Shelf box [10 Units]; Discontinued: 2018-05-29; Not in Commercial Distribution

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-15
• 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