AccessGUDID - DEVICE: IMEDIPLUS Electronic Stethoscope DS3011A (04719874400040)

GUDID

Device Identifier (DI) Information

Brand Name: IMEDIPLUS Electronic Stethoscope DS3011A
Version or Model: DS3011AP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMEDIPLUS INC.

Primary DI Number: 04719874400040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658869745 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13754	Electronic acoustic stethoscope	An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQD	Stethoscope, Electronic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173663	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8e1df695-9fd0-46b9-b5cf-b3313774b09d
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: January 08, 2019