CAREFLOW(TM) 1 LUMEN 3FR X 150MM

Basic Information

• Brand Name: CAREFLOW(TM) 1 LUMEN 3FR X 150MM
• Primary DI: 00886333616404
• Version / Model: 681640
• Catalog Number: 681640
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Labeler DUNS: 595138793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: c7d3f153-40ed-4bea-a8ef-ec06e6f35a84

Device Description

Kits Contents : Catheter 3FR OD 1.10mmx150mm; J guidewire OD 0.46mmx450mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Floswitch(TM) Overneedle Introducer 20G OD 1.0mmx45mm, Dilator 4FR OD 1.27mm ID 0.51mm & Floswitch(TM).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50886333616409	GS1	Tyvek Tray	100	In Commercial Distribution
Primary	00886333616404	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter 3FR OD 1.10mmx150mm