MEDRAD® Stellant FLEX Syringe Kit

Basic Information

• Brand Name: MEDRAD® Stellant FLEX Syringe Kit
• Primary DI: 00616258010625
• Version / Model: FLEXD-200-SPK
• Catalog Number: FLEXD-200-SPK
• Company Name: BAYER MEDICAL CARE INC.
• Labeler DUNS: 058716649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-22
• Public Version: 1
• Public Version Date: 2018-12-24
• Public Version Status: New
• Public Device Record Key: cb6641b3-ac2f-472e-96c2-9c9c162cc9aa

Device Description

Stellant Dual 200mL Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (STLNT,KIT,SYR,CT,D,SPK,FLS3,200ML,RW) (85071041)

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
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	870.1650	2
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
Package	70616258010624	GS1		600	In Commercial Distribution	9999-12-31
Primary	00616258010625	GS1
Package	50616258010620	GS1		20	In Commercial Distribution	9999-12-31
Package	40616258010623	GS1		20	In Commercial Distribution	9999-12-31

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173773	000