A2000 Multi-use Syringe Kit

Basic Information

• Brand Name: A2000 Multi-use Syringe Kit
• Primary DI: 10841716101271
• Version / Model: 014612
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• Labeler DUNS: 926684994
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2020-04-20
• Public Version Status: Update
• Public Device Record Key: 8a19c5c7-8d47-4699-9339-1a508decae2f
• Distribution End Date: 2019-02-27

Device Description

A2000 Multi-use Syringe Kit, p/n 700334-017 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47259	Contrast medium injection system syringe	A component of a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is primarily an exchangeable plunger-in-barrel chamber for the medium/solution; the movement of the plunger (piston) is controlled by the contrast medium/solution injector. It is typically made of plastic materials and can be reused for several patients, e.g., up to five patients. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841716101271	GS1
Package	30841716101275	GS1	Shelf box	10	Not in Commercial Distribution
Package	30841716101831	GS1	Shelf Box	10	Not in Commercial Distribution