Multi-use Syringe Kit

GUDID 30841716100087

Model A2000V, p/n 701259-003 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system syringe

• Primary Device ID: 30841716100087
• NIH Device Record Key: bf078348-a3ec-48a5-a068-12aee1dcd367
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-use Syringe Kit
• Version Model Number: 014113
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841716100083 [Primary]
GS1	30841716100087 [Package]; Contains: 10841716100083; Package: Shelf box [10 Units]; 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: 2020-04-20
• Device Publish Date: 2016-09-09

On-Brand Devices [Multi-use Syringe Kit]

• 30841716101633: Model A2000V, p/n 701259-006 Kit Contents: 100mL contrast reservoir and tubing with contrast spi
• 30841716100087: Model A2000V, p/n 701259-003 Kit Contents: 100mL contrast reservoir and tubing with contrast spi