A1000 Single Use Syringe Kit

Basic Information

• Brand Name: A1000 Single Use Syringe Kit
• Primary DI: 10841716102155
• Version / Model: 016606
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• Labeler DUNS: 926684994
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-09
• Public Version: 2
• Public Version Date: 2020-04-20
• Public Version Status: Update
• Public Device Record Key: 685523a5-ebf1-4bdf-8dbf-72f3099ffe07

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
Package	30841716102159	GS1		10	In Commercial Distribution
Primary	10841716102155	GS1

Premarket Submissions

Submission Number	Supplement Number
K191060	000