AccessGUDID - DEVICE: IMEDIPLUS TS-3000S Single Head Stethoscope Black (04719874400156)

GUDID

Device Identifier (DI) Information

Brand Name: IMEDIPLUS TS-3000S Single Head Stethoscope Black
Version or Model: TS-3000S Black
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMEDIPLUS INC.

Primary DI Number: 04719874400156
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658869745 *Terms of Use

Device Description: IMEDIPLUS TS-3000S Black Single Head Stethoscope aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
13755	Mechanical external stethoscope	A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDE	Stethoscope, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 28e8c936-b91e-444f-b4b5-19b8801a2600
Public Version Date: November 25, 2024
Public Version Number: 2
DI Record Publish Date: June 23, 2020