EkoSonic®

Basic Information

• Brand Name: EkoSonic®
• Primary DI: 00858593006493
• Version / Model: 600-30000
• Catalog Number: 600-30000
• Company Name: EKOS CORPORATION
• Labeler DUNS: 943488429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-22
• Public Version: 6
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 0e31ace7-8d0b-48e4-b0d6-1534639e9914

Device Description

The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors parameters during operation via the CIC. The Control Unit also provides the user interface for operator control. The EkoSonic® Control Unit is intended exclusively for use with the EkoSonic® Device.

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
59025	Ultrasound thrombolysis system control unit	An electrically-powered device designed to generate high-frequency, low-energy ultrasound for intravascular administration to help disrupt clotted blood (i.e., a thrombus or thromboembolus). It is designed to be used with a dedicated infusion catheter for thrombolytic drug administration. The ultrasound is intended to prepare the clot by unwinding the fibrin strands, therefore enabling increased drug permeation through the clot to the vessel wall. It typically consists of a user interface, piezoelectric transducer, and one or more rechargeable battery for independent/mobile use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858593006493	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius