RAYFLOW

Basic Information

• Brand Name: RAYFLOW
• Primary DI: 03700385769154
• Version / Model: RFW62U
• Company Name: HEXACATH
• Labeler DUNS: 398534461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-20
• Public Version: 1
• Public Version Date: 2023-07-28
• Public Version Status: New
• Public Device Record Key: 7e951635-9399-4c94-80eb-9c27e4cc91fe

Device Description

Multipurpose infusion catheter Rayflow

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: Yes
• 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
KRA	Catheter, Continuous Flush	Cardiovascular	870.1210	2
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36205	Coronary artery infusion catheter	A sterile flexible tube, typically with a double-lumen, designed to access the coronary artery vasculature for local infusion of diagnostic or therapeutic solutions (e.g., angiographic contrast medium, heparin solution, saline), and often to function as a passage for a guidewire to assist its placement in the coronary artery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700385769154	GS1

Premarket Submissions

Submission Number	Supplement Number
K222023	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius