Coeur

Basic Information

• Brand Name: Coeur
• Primary DI: M297132000
• Version / Model: C405-3200
• Catalog Number: C405-3200
• 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: c3217661-f47c-42ae-9bee-cd3bca47f7db

Device Description

20 in. Transfer Set with swabable Valve and Long Spike

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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2
FPK	Tubing, Fluid Delivery	General Hospital	880.5440	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	M297132006	HIBCC	shipper	2	In Commercial Distribution
Package	M297132005	HIBCC	case	50	In Commercial Distribution
Primary	M297132000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063114	000

Device Sizes

Type	Value	Unit	Text
Length	20	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.