FDA.reportPublic FDA data

Cardiart Electronic Stethoscope

Primary DI
04719874400019
Brand
Cardiart Electronic Stethoscope
Company
IMEDIPLUS INC.
Model
DS101
Device description
The Electronic Stethoscope DS101 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
K182196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182196000Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-StethImediplus, Inc.2018-09-11DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719874400019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874400019047198744000194719874400019

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
04719874400026Omni-Steth Electronic StethoscopeOmni-Steth2019-01-08
04719874400040IMEDIPLUS Electronic Stethoscope DS3011ADS3011AP2019-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-05-18
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DQD2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Devices, Inc.DQD2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceEko Devices, Inc.DQD2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceEko Devices, Inc.DQD2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGEko Devices, Inc.DQD2026-04-03
00860011561736Stethophone ProSparrow Acoustics Inc.DQD2026-02-18
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Devices, Inc.DQD2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Devices, Inc.DQD2026-01-29
08809427311032SkeeperSmartsound CorportationDQD2026-01-12
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceEko Devices, Inc.DQD2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceEko Devices, Inc.DQD2025-11-07
06429811134003Keikku Digital StethoscopeLapsi Health Holding B.V.DQD2025-10-16
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceEko Devices, Inc.DQD2025-10-15
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryEko Devices, Inc.DQD2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteEko Devices, Inc.DQD2025-10-15
00850010298726CORE 500 Digital Stethoscope - Electric Pink ChestpieceEko Devices, Inc.DQD2025-08-12
00850010298757CORE 500 Digital Stethoscope - Electric Pink EarpieceEko Devices, Inc.DQD2025-08-12
00850010298788CORE 500 Digital Stethoscope - Bundle-SLVEko Devices, Inc.DQD2025-08-12
00850010298795CORE 500 Digital Stethoscope - Bundle-BLKEko Devices, Inc.DQD2025-08-12
00850010298801CORE 500 Digital Stethoscope - Bundle-CHPEko Devices, Inc.DQD2025-08-12
00850010298818CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club PinkEko Devices, Inc.DQD2025-08-12
00850010298733CORE 500 Digital Stethoscope - Ruby Earpiece Eko Devices, Inc.DQD2025-03-19
00850010298245CORE 500 Digital Stethoscope FIGS Earpiece - BlackEko Devices, Inc.DQD2025-03-18
00850010298252CORE 500 Digital Stethoscope FIGS Earpiece - GreyEko Devices, Inc.DQD2025-03-18
00850010298269CORE 500 Digital Stethoscope FIGS Earpiece - MauveEko Devices, Inc.DQD2025-03-18
00850010298276CORE 500 Digital Stethoscope FIGS Earpiece - SandstoneEko Devices, Inc.DQD2025-03-18
00850010298306CORE 500 Digital Stethoscope FIGS Earpiece - Royal BlueEko Devices, Inc.DQD2025-03-18
00850010298313CORE 500 Digital Stethoscope FIGS Earpiece - MossEko Devices, Inc.DQD2025-03-18
00850010298399CORE 500 Digital Stethoscope FIGS Earpiece - Pink RibbonEko Devices, Inc.DQD2025-03-18