FDA.reportPublic FDA data

Kosmos Bridge - Refurbished

Primary DI
09353278000458
Brand
Kosmos Bridge - Refurbished
Company
ECHONOUS, INC.
Model
R006030
Published
2020-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQDStethoscope, Electronic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQDStethoscope, ElectronicCardiovascular2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193518000KOSMOSEchoNous, Inc.2020-03-26IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353278000458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353278000458093532780004589353278000458

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound/electrocardiograph/stethoscope unitAn electrically-powered modular device intended for general medical examination using ultrasound, electrocardiograph (ECG) and auscultation modalities, with a user interface that enables synchronized data display and recording. It consists of a multi-purpose transducer designed for transmitting/receiving ultrasound and sensing sound signals, to which an ECG lead assembly can be attached, and a connected image display monitor (e.g., tablet) with dedicated software; in addition to the integrated electronic stethoscope, it may also allow connection of a stethoscope headset for the user to directly hear sounds.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080481089
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09353278000878Kosmos OTS iOS Software Package (5.0)v5.0P0087912026-03-25
09353278000830KosmosP0080422025-08-08
09353278000847KosmosP0080412025-08-08
09353278000823Kosmos OTS iOS iOS 4.X2025-02-21
09353278000854Kosmos LinkP0083922025-02-21
09353278000441Kosmos Torso - RefurbishedR0060252020-12-11
09353278000465Kosmos Accessories - US - RefurbishedR0062082020-12-11
09353278000489Binaural Headset - RefurbishedR0061152020-12-11
09353278000137Kosmos TorsoP0060252020-05-06
09353278000212Kosmos Binaural HeadsetP0061152020-05-06
09353278000250Kosmos Accessories - InternationalP0061052020-05-06
09353278000267Kosmos Accessories - USP0062082020-05-06
09353278000144Kosmos ECG Patient Cable - USP0057792020-05-06
09353278000243Kosmos ECG Patient Cable - InternationalP0061862020-05-06
09353278000762Kosmos OTS iOS P0079442024-05-06
09353278000656Kosmos UPP0065982022-02-08
09353278000632Kosmos Power PackP0076402023-03-10
09353278000724Kosmos Power Pack (Refurbished)R0076402023-03-10
09353278000663EchoNous Samsung S8 Tablet with SoftwareP0076352023-03-08
09353278000670EchoNous Samsung S8 Tablet with Software (Refurbished)R0076352023-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413835153Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
00884838096745Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278723963NAGE Healthcare Japan CorporationIYO2025-10-15
00195278723963NAGE Healthcare Japan CorporationIYN2025-10-15
00884838129276Ultrasound WorkspacePhilips Ultrasound LLCIYN2025-08-29
00195278875860VscanGE Vingmed Ultrasound A/SIYO2025-07-04
00195278875860VscanGE Vingmed Ultrasound A/SIYN2025-07-04
00195278910509VolusonGE Ultrasound Korea Ltd.IYO2025-06-04