Single-use Syringe Kit

GUDID 30841716102166

Model A1000V, p/n 701259-007 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system syringe

• Primary Device ID: 30841716102166
• NIH Device Record Key: 9fd499ff-8af6-49f8-a6b1-b9cdfecbfe4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 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	10841716102162 [Primary]
GS1	30841716102166 [Package]; Contains: 10841716102162; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-20
• Device Publish Date: 2019-10-16

On-Brand Devices [Single-use Syringe Kit]

• 30841716102166: Model A1000V, p/n 701259-007 Kit Contents: 100mL contrast reservoir and tubing with contrast spi
• 30841716102616: Model A1000V, p/n 701259-012 Kit Contents: 100mL contrast reservoir and tubing with contrast spi