Cleaner XT™ Rotational Thrombectomy System

Basic Information

• Brand Name: Cleaner XT™ Rotational Thrombectomy System
• Primary DI: 00886333222322
• Version / Model: 700109XT
• Catalog Number: 700109XT
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2018-09-13
• Public Version Status: Update
• Public Device Record Key: cb8415be-3478-4ad1-8375-8ca651c772b4

Device Description

Cleaner XT™ Rotational Thrombectomy System 6F x 135cm

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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
58172	Thrombectomy rotational catheter	A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886333222322	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6F x 135cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Type B Applied Part
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and Away from Sunlight