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
00195278840202MACGe Medical Systems Information Technologies, Inc.DPS2026-10-13
06973660370001MinttiSuzhou Melodicare Medical Technology Co., Ltd.DQD2026-10-10
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYN2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DQD2026-10-01
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DPS2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DQD2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackEko Health, Inc.DQD2026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryEko Health, Inc.DQD2026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetEko Health, Inc.DQD2026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificEko Health, Inc.DQD2026-10-01
00810209880255CORE 300™ Digital Stethoscope - CloudEko Health, Inc.DQD2026-10-01
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYN2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24