A1000 Single Use Syringe Kit

GUDID 30841716102159

A1000 Single Use Syringe Kit, p/n 801060-003 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system syringe

• Primary Device ID: 30841716102159
• NIH Device Record Key: 685523a5-ebf1-4bdf-8dbf-72f3099ffe07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A1000 Single Use Syringe Kit
• Version Model Number: 016606
• 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	10841716102155 [Primary]
GS1	30841716102159 [Package]; Contains: 10841716102155; 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: 2019-10-09

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