RadialFlo™

Basic Information

• Brand Name: RadialFlo™
• Primary DI: 10884450363956
• Version / Model: 10884450363956
• Catalog Number: 682315/A
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Labeler DUNS: 595138793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-02-28
• Public Version: 2
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: 1ef39c4d-b45b-463c-8df3-2c88cd865af8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10689	Arterial blood pressure catheter	A sterile, thin flexible tube intended for short-term (<= 30 days) percutaneous placement within an artery for continuous blood pressure monitoring. It is typically interfaced with a parent device (e.g., external blood pressure transducer) and may be used for arterial blood sampling. The catheter is flushed between sampling procedures; it is not intended to be used for the administration of medication or fluids. Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire, adaptor) may be included. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884450363953	GS1		20	In Commercial Distribution
Primary	10884450363956	GS1
Unit of Use	00884450363959	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length-45 mm