Omni-Steth Electronic Stethoscope

GUDID 04719874400026

The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posteri

IMEDIPLUS INC.

Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope
Primary Device ID04719874400026
NIH Device Record Key591e4d37-9aaa-4805-b3f0-674d72bdcaf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni-Steth Electronic Stethoscope
Version Model NumberOmni-Steth
Company DUNS658869745
Company NameIMEDIPLUS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719874400026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQDStethoscope, Electronic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-08
Device Publish Date2019-01-08

Devices Manufactured by IMEDIPLUS INC.

04719874400149 - IMEDIPLUS TS-3000S Single Head Stethoscope Blue2020-07-01 IMEDIPLUS TS-3000S Blue Single Head Stethoscope aids to the auscultation needs and is designed to suit the individual requiremen
04719874400156 - IMEDIPLUS TS-3000S Single Head Stethoscope Black2020-07-01 IMEDIPLUS TS-3000S Black Single Head Stethoscope aids to the auscultation needs and is designed to suit the individual requireme
04719874400163 - IMEDIPLUS TS-3000S Single Head Stethoscope Wine Red2020-07-01 IMEDIPLUS TS-3000S Wine Red Single Head Stethoscope aids to the auscultation needs and is designed to suit the individual requir
04719874400170 - IMEDIPLUS TS-3000D Dual Head Stethoscope Blue2020-07-01 IMEDIPLUS TS-3000D Dual Head Stethoscope Blue aids to the auscultation needs and is designed to suit the individual requirement
04719874400187 - IMEDIPLUS TS-3000D Dual Head Stethoscope Black2020-07-01 IMEDIPLUS TS-3000D Dual Head Stethoscope Black aids to the auscultation needs and is designed to suit the individual requirement
04719874400194 - IMEDIPLUS TS-3000D Dual Head Stethoscope Wine Red2020-07-01 IMEDIPLUS TS-3000D Dual Head Stethoscope Wine Red aids to the auscultation needs and is designed to suit the individual requirem
04719874400200 - Cardiart TS6000 Premium Cardiology Stethoscope Black2020-07-01 Cardiart TS6000 Premium Cardiology Stethoscope Black aids to the auscultation needs and is designed to suit the individual requi
04719874400217 - Cardiart TS3000PD Pediartic Dual Head Stethoscope Black2020-07-01 Cardiart TS3000PD Pediartic Dual Head Stethoscope Black aids to the auscultation needs and is designed to suit the individual re

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.