A1000 Single Use Syringe Kit

GUDID 30841716102609

A1000 Single Use Syringe Kit, p/n 701669-009 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system syringe

• Primary Device ID: 30841716102609
• NIH Device Record Key: dbe3c24f-0102-43bd-8440-396e0c982c62
• Commercial Distribution Discontinuation: 2021-03-17
• Commercial Distribution Status: Not 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: 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	10841716102605 [Primary]
GS1	30841716102609 [Package]; Contains: 10841716102605; Package: Shelf Box [10 Units]; Discontinued: 2021-03-17; Not 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: 2024-05-27
• Device Publish Date: 2020-11-06

On-Brand Devices [A1000 Single Use Syringe Kit]

• 30841716102159: A1000 Single Use Syringe Kit, p/n 801060-003 Kit Contents: 100mL contrast reservoir and tubing w
• 30841716102609: A1000 Single Use Syringe Kit, p/n 701669-009 Kit Contents: 100mL contrast reservoir and tubing w