FDA.reportPublic FDA data

IMEDIPLUS Electronic Stethoscope DS3011A

Primary DI
04719874400040
Brand
IMEDIPLUS Electronic Stethoscope DS3011A
Company
IMEDIPLUS INC.
Model
DS3011AP
Device description
The IMEDIPLUS Electronic Stethoscope DS3011A is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest-piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
Published
2019-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQDStethoscope, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQDStethoscope, ElectronicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173663000Electronic Stethoscope DS3011AImediplus, Inc.2018-08-17DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874400040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874400040047198744000404719874400040

GMDN Terms#

Term, Definition table
TermDefinition
Electronic stethoscopeAn external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. It will typically be connected to a computer so that the results can be presented on a screen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658869745
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719874400088Cardiart TS6000 Premium Cardiology StethoscopeTS6000 Premium2019-09-03
04719874400095Cardiart TS3000PD Pediartic Dual Head StethoscopeTS3000PD2019-09-03
04719874400101IMEDIPLUS TS-3000S Single Head StethoscopeTS-3000S2019-09-03
04719874400118IMEDIPLUS TS-3000D Dual Head StethoscopeTS-3000D2019-09-03
04719874400149IMEDIPLUS TS-3000S Single Head Stethoscope BlueTS-3000S Blue2020-06-23
04719874400156IMEDIPLUS TS-3000S Single Head Stethoscope BlackTS-3000S Black2020-06-23
04719874400163IMEDIPLUS TS-3000S Single Head Stethoscope Wine RedTS-3000S Wine Red2020-06-23
04719874400170IMEDIPLUS TS-3000D Dual Head Stethoscope BlueTS-3000D Blue2020-06-23
04719874400187IMEDIPLUS TS-3000D Dual Head Stethoscope BlackTS-3000D Black2020-06-23
04719874400194IMEDIPLUS TS-3000D Dual Head Stethoscope Wine RedTS-3000D Wine Red2020-06-23
04719874400200Cardiart TS6000 Premium Cardiology Stethoscope BlackTS6000 Premium Black2020-06-23
04719874400217Cardiart TS3000PD Pediartic Dual Head Stethoscope BlackTS3000PD Black2020-06-23
04719874400125Cardiart Dual Head Stethoscope TS3000DL (Double-lumen)TS3000DL2019-09-11
04719874400019Cardiart Electronic StethoscopeDS1012019-01-08
04719874400026Omni-Steth Electronic StethoscopeOmni-Steth2019-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973660370001MinttiSuzhou Melodicare Medical Technology Co., Ltd.DQD2026-10-10
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DQD2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DQD2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DQD2026-10-01
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
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-06-22
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DQD2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DQD2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DQD2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DQD2026-06-12
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DQD2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DQD2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-05-18
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Health, Inc.DQD2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Health, Inc.DQD2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceEko Health, Inc.DQD2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceEko Health, Inc.DQD2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGEko Health, Inc.DQD2026-04-03
00860011561736Stethophone ProSparrow Acoustics Inc.DQD2026-02-18
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Health, Inc.DQD2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Health, Inc.DQD2026-01-29
08809427311032SkeeperSmartsound CorportationDQD2026-01-12
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceEko Health, Inc.DQD2025-11-07