A1000V Single Use Syringe Kit

GUDID 30841716102524

A1000V Single Use Syringe Kit Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe Contrast medium injection system syringe

• Primary Device ID: 30841716102524
• NIH Device Record Key: 1709cd3d-037e-4cac-83df-972aef51729e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A1000V Single Use Syringe Kit
• Version Model Number: 016605
• 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: true
• 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	10841716102520 [Primary]
GS1	30841716102524 [Package]; Contains: 10841716102520; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191060

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-05
• Device Publish Date: 2024-05-28

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