A2000 Multi-use Syringe Kit

GUDID 10841716101684

A2000 Multi-use Syringe Kit, p/n 701669-002 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps

ACIST MEDICAL SYSTEMS, INC.

Contrast medium injection system syringe

• Primary Device ID: 10841716101684
• NIH Device Record Key: 41240884-c4a3-4ca0-a40d-dfc856dc5311
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A2000 Multi-use Syringe Kit
• Version Model Number: 014612
• 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: false
• 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	10841716101684 [Primary]
GS1	30841716101688 [Package]; Package: Shelf Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171646

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: 2018-11-30

On-Brand Devices [A2000 Multi-use Syringe Kit]

• 30841716101916: A2000 Multi-use Syringe Kit, p/n 700334-024 Kit Contents: 100mL contrast reservoir and tubing wi
• 10841716101271: A2000 Multi-use Syringe Kit, p/n 700334-017 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716101268: A2000 Multi-use Syringe Kit, p/n 701277-004 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716101534: A2000 Multi-use Syringe Kit, p/n 701277-007 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716100032: A2000 Multi-use Syringe Kit, p/n 700334-016 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716102111: A2000 Multi-use Syringe Kit, p/n 700334-027 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716101947: A2000 Multi-use Syringe Kit, p/n 701669-001 Kit Contents: 100mL contrast reservoir and tubing wi
• 10841716101684: A2000 Multi-use Syringe Kit, p/n 701669-002 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716101527: A2000 Multi-use Syringe Kit, p/n 700334-022 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716100063: A2000 Multi-use Syringe Kit, p/n 700334-014 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716100056: A2000 Multi-use Syringe Kit, p/n 700334-010 Kit Contents: 100mL contrast reservoir and tubing wi
• 30841716100049: A2000 Multi-use Syringe Kit, p/n 700334-015 Kit Contents: 100mL contrast reservoir and tubing wi
• 10841716100021: A2000 Multi-use Syringe Kit, p/n 701277-003 Kit Contents: 100mL contrast reservoir and tubing wi