Cleaner Plus™

Basic Information

• Brand Name: Cleaner Plus™
• Primary DI: 00886333225750
• Version / Model: 70001510
• Catalog Number: 70001510
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-28
• Public Version: 4
• Public Version Date: 2023-04-18
• Public Version Status: Update
• Public Device Record Key: 4917eab2-789e-4bfd-b5d7-c4710a4695ed
• Distribution End Date: 2023-04-17

Device Description

Cleaner Plus™ Thrombectomy System 10F (OD) x 65cm

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: 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
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886333225750	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211798	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10F (OD) x 65cm

Storage Conditions

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