Disposable MRI Kit for 65/115 MR Injector System

Basic Information

• Brand Name: Disposable MRI Kit for 65/115 MR Injector System
• Primary DI: 00616258007359
• Version / Model: SSQK 65/115VS
• Catalog Number: SSQK 65/115VS
• Company Name: BAYER MEDICAL CARE INC.
• Labeler DUNS: 058716649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-10-19
• Public Version Status: Update
• Public Device Record Key: d2ec6ea2-7b79-4091-834d-767e489fe011

Device Description

Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1 large spike, 1 small spike for contrast, 96" low pressure tubing with T-connector and Check Valve) (KIT,65/115ML,96"CT/CV,MRI, MC, LA) (60728575)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
15286	Angiographic syringe	A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616258007359	GS1
Package	10616258007356	GS1		50	In Commercial Distribution	9999-12-31

Customer Contacts

• Phone: [phone]
• Email: [email protected]