FDA.reportPublic FDA data

EkoSonic®

Primary DI
00858593006493
Brand
EkoSonic®
Company
EKOS CORPORATION
Model
600-30000
Catalog number
600-30000
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.
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140151000EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNITBtg International, Inc.2014-05-21QEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858593006493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858593006493008585930064938585930064930858593006493

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound thrombolysis system control unitA mains electricity (AC-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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-400-3567EKOSCustomerService@ekoscorp.com

Regulatory Flags#

DUNS number
943488429
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858593006509EkoSonic®700-10302700-103022016-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506067342TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067359TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067366TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067373TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067380TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067397TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067403TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067410TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyKRA2026-05-30
00885403523819VAMPBecton, Dickinson And CompanyKRA2026-05-30
00884450826492Fountain®Merit Medical Systems, Inc.KRA2026-05-29
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023955Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01