BT2000 Automated Manifold Kit

GUDID 30841716101565

Model BT2000 p/n 701671-002 Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system administration set

• Primary Device ID: 30841716101565
• NIH Device Record Key: 33bba1ec-5b5e-4b40-b824-d241670b5cc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BT2000 Automated Manifold Kit
• Version Model Number: 014613
• 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: true
• 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	10841716101561 [Primary]
GS1	30841716101565 [Package]; Contains: 10841716101561; Package: Shelf Box [10 Units]; In Commercial Distribution
GS1	30841716102623 [Package]; Contains: 10841716101561; Package: Shelf Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171646

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: 2
• Public Version Date: 2021-02-19
• Device Publish Date: 2020-11-06

On-Brand Devices [BT2000 Automated Manifold Kit]

• 30841716101923: Model BT2000 p/n 700287-023 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716101664: Model BT2000 p/n 700287-019 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716100643: Model BT2000 p/n 700287-021 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716100322: Model BT2000 p/n 701279-004 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716100308: Model BT2000 p/n 700287-017 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716102128: Model BT2000 p/n 700287-026 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716101978: Model BT2000 p/n 701671-001 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716101565: Model BT2000 p/n 701671-002 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716100315: Model BT2000 p/n 701279-002 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716100292: Model BT2000 p/n 700287-016 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716100285: Model BT2000 p/n 700287-013 Kit Contents: manifold with saline and contrast ports, saline tubing
• 30841716100278: Model BT2000 p/n 700287-012 Kit Contents: manifold with saline and contrast ports, saline tubing