Coeur

Basic Information

• Brand Name: Coeur
• Primary DI: M297115590
• Version / Model: C405-1559
• Catalog Number: C405-1559
• Company Name: COEUR, INC.
• Labeler DUNS: 132515441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-14
• Public Version: 3
• Public Version Date: 2019-02-04
• Public Version Status: Update
• Public Device Record Key: 3b7f9c94-33b9-4e63-b996-feba8ba967ef

Device Description

1500mm Straight Extension Y-Line with 1 Check Valve

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
44685	Radiographic procedure tubing	A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M297115595	HIBCC	case	50	In Commercial Distribution
Primary	M297115590	HIBCC
Package	M297115596	HIBCC	shipper	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K942381	000

Device Sizes

Type	Value	Unit	Text
Length	1500	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep product in clean, dry location. Avoid direct rays, heat and high humidity, and ultraviolet rays such as a germicidal light