AccessGUDID - DEVICE: Stethee Pro Central Web Application (09351356000055)

GUDID

Device Identifier (DI) Information

Brand Name: Stethee Pro Central Web Application
Version or Model: 2.0.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M3DICINE PTY LTD

Primary DI Number: 09351356000055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 757852710 *Terms of Use

Device Description: Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.

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?
13017	Phonocardiograph	A device for recording heart sounds at the body surface through the heart's actions which cause vibrations that are transmitted through organs and tissue to the body surface. These are detected by microphones, processed in an electroacoustic transducer, and give sound characteristics in a phonocardiogram. This is used to assess the low frequency sounds (atrial and ventricular gallops), and high frequency sounds (mitral regurgitation and ventricular septal defect). Some also record subsonic frequencies (a few Hertz) considered as vibrations, typically recorded by an apexcardiograph. This method may also be integrated in other electrocardiograph (ECG) devices.	Obsolete	false
41177	Stethoscope application software	A data application program designed for use in, or together with, a computer, e.g., a standard personal computer (PC), and an electronic stethoscope. This software program will permit, e.g., the visualization of the sound picture which can be used for enhanced diagnostic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQC	Phonocardiograph
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency
BZQ	Monitor, Breathing Frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193631	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: 3207b18e-8b8a-43e0-b48c-adb26c0260b2
Public Version Date: December 31, 2020
Public Version Number: 1
DI Record Publish Date: December 23, 2020