Coeur

Basic Information

• Brand Name: Coeur
• Primary DI: M297129620
• Version / Model: C405-2962
• Catalog Number: C405-2962
• 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: 7ad829f7-f427-46af-9434-f7370fbfc21d

Device Description

96 in. Coiled Y-Line with 2 Check Valves

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	M297129626	HIBCC	shipper	2	In Commercial Distribution
Package	M297129625	HIBCC	case	50	In Commercial Distribution
Primary	M297129620	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K942381	000

Device Sizes

Type	Value	Unit	Text
Length	96	Inch

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.